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2 days ago
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RAD 2025: Long-Term Data on Nemluvio ® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years
ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD) today announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio in moderate-to-severe atopic dermatitis. The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years. 1 These data will be presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference, taking place from June 6-7, 2025. BALDO SCASSELLATI SFORZOLINI, M.D., PHD. GALDERMA Expand Atopic dermatitis affects more than 230 million people worldwide. 3 Often reported as one of patients' most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians. 4-7 Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31. 3,8,9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis. 8,10 Nemluvio is also the first and only biologic approved for atopic dermatitis as well as prurigo nodularis with four-week dosing intervals from the start of treatment, and the only option to move to eight-week dosing intervals for appropriate patients with atopic dermatitis. 9 'The relentless itch of atopic dermatitis is not just a symptom; it's a constant burden that disrupts sleep, concentration, and the simple joys of life. Nemolizumab has demonstrated its impact on both itch and skin lesions in atopic dermatitis extensively over the years, and these new data, demonstrating its benefit up to two years, add another layer of confidence to that.' PROFESSOR JONATHAN SILVERBERG Expand The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe atopic dermatitis up to five years and includes more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients. 1 Results to be presented at the RAD Conference will show that Nemluvio is associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years. 1 At week 104 in evaluable patients, the interim analysis shows that: More than 85% achieved a 75% reduction in the Eczema Area and Severity Index (EASI) 1 Approximately 85% and 70% achieved an at least four-point improvement in itch, and being itch free or nearly itch free, respectively, when assessed using the SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Pruritus score. Improvements in sleep mirrored those in itch 1 Approximately 60% reached clearance or almost-clearance of skin lesions when assessed using the Investigator's Global Assessment (IGA) score 1 Patients' quality of life improved over time, as measured by the Dermatology Life Quality Index (DLQI) 1 Results also reinforce Nemluvio's rapid onset of action on itch and skin at Week 4, with 49% of patients who entered the long-term extension study naïve to Nemluvio achieving a 75% reduction in the EASI, and 69% achieving an at least four-point improvement in itch when assessed using the SCORAD VAS Pruritus score. 1 Nemluvio was well tolerated in the long-term treatment of atopic dermatitis and no new safety signals were identified. 1 Additional data from both the ARCADIA program in atopic dermatitis, as well as from the OLYMPIA open-label extension study in prurigo nodularis will be presented at RAD 2025, reinforcing Nemluvio's rapid impact on key symptoms of atopic dermatitis, and its long-term efficacy in prurigo nodularis. 11,12 Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis. 9 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. 9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional regulatory submissions and reviews are ongoing. More details on Galderma's scientific presentations at RAD can be found here. About Nemluvio Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga ® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients. 13,14 About atopic dermatitis Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions. 3,15,16 It affects more than 230 million people worldwide. 3 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis. 17 Important Safety Information Indications: NEMLUVIO ® (nemolizumab-ilto) is a prescription medicine used: to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis or AD) in combination with prescription therapies used on the skin (topical) when the eczema is not well controlled by topical therapies alone. It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age. to treat adults with prurigo nodularis. It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age. Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you: are scheduled to receive any vaccination. You should not receive a live vaccine right before or during treatment with NEMLUVIO. are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: Breathing problems or wheezing Swelling of the face, lips, mouth, tongue, or throat Fainting, dizziness, feeling lightheaded Fast pulse Swollen lymph nodes Joint pain Fever Skin rash (red or rough skin) Nausea or vomiting General ill feeling Cramps in your stomach area The most common side effects of NEMLUVIO include: Eczema: headache, joint pain, hives (itchy red rash or wheals), and muscle aches Prurigo Nodularis: headache and skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches) These are not all of the possible side effects of NEMLUVIO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088. Please see full Prescribing Information including Patient Information. About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: References Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0 Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286-1 Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi: 10.1016/ Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7:102:adv00830. doi: 10.2340/actadv.v102.3932 Durno N, et al. Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi: 10.1080/09546634.2024.2417966 Penton H, et al. Assessing Response in Atopic Dermatitis: A Systematic Review of the Psychometric Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/ Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025 Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi: 10.1002/cti2.1390 Silverberg JI, et al. Nemolizumab was associated with rapid and significant improvements in itch and sleep in patients with moderate-to-severe atopic dermatitis: Results from two global phase 3 pivotal studies (ARCADIA 1 and ARCADIA 2). Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Yosipovitch G, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025 Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911 Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond)
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2 days ago
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RAD 2025: Long-Term Data on Nemluvio® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years
New interim two-year data from a long-term extension study of Nemluvio in atopic dermatitis reinforce its rapid onset of action and demonstrate its lasting impact across multiple clinical and patient reported outcomes including itch and skin lesions1 Results build on data from the phase III ARCADIA program, showing Nemluvio's consistent safety profile and sustained and increased improvements in efficacy outcomes in atopic dermatitis patients during prolonged treatment up to two years1,2 Two-year data from a long-term extension study of Nemluvio in prurigo nodularis will also be presented later in June at the International Congress of Dermatology ZUG, Switzerland, June 06, 2025--(BUSINESS WIRE)--Galderma (SIX: GALD) today announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio in moderate-to-severe atopic dermatitis. The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years.1 These data will be presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference, taking place from June 6-7, 2025. "With Nemluvio now being launched in several countries, it's so encouraging that we continue to see its robust evidence base expand. Long-term data is pivotal to this, highlighting the profound impact this innovative treatment can have in atopic dermatitis well into the future." BALDO SCASSELLATI SFORZOLINI, M.D., PHD. GLOBAL HEAD OF RESEARCH & DEVELOPMENT GALDERMA Atopic dermatitis affects more than 230 million people worldwide.3 Often reported as one of patients' most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians.4-7 Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.3,8,9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis.8,10 Nemluvio is also the first and only biologic approved for atopic dermatitis as well as prurigo nodularis with four-week dosing intervals from the start of treatment, and the only option to move to eight-week dosing intervals for appropriate patients with atopic dermatitis.9 "The relentless itch of atopic dermatitis is not just a symptom; it's a constant burden that disrupts sleep, concentration, and the simple joys of life. Nemolizumab has demonstrated its impact on both itch and skin lesions in atopic dermatitis extensively over the years, and these new data, demonstrating its benefit up to two years, add another layer of confidence to that."PROFESSOR JONATHAN SILVERBERG LEAD INVESTIGATOR OF THE ARCADIA CLINICAL PROGRAM, PROFESSOR OF DERMATOLOGY, GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES, UNITED STATES The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe atopic dermatitis up to five years and includes more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients.1 Results to be presented at the RAD Conference will show that Nemluvio is associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years.1 At week 104 in evaluable patients, the interim analysis shows that: More than 85% achieved a 75% reduction in the Eczema Area and Severity Index (EASI)1 Approximately 85% and 70% achieved an at least four-point improvement in itch, and being itch free or nearly itch free, respectively, when assessed using the SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Pruritus score. Improvements in sleep mirrored those in itch1 Approximately 60% reached clearance or almost-clearance of skin lesions when assessed using the Investigator's Global Assessment (IGA) score1 Patients' quality of life improved over time, as measured by the Dermatology Life Quality Index (DLQI)1 Results also reinforce Nemluvio's rapid onset of action on itch and skin at Week 4, with 49% of patients who entered the long-term extension study naïve to Nemluvio achieving a 75% reduction in the EASI, and 69% achieving an at least four-point improvement in itch when assessed using the SCORAD VAS Pruritus score.1 Nemluvio was well tolerated in the long-term treatment of atopic dermatitis and no new safety signals were identified.1 Additional data from both the ARCADIA program in atopic dermatitis, as well as from the OLYMPIA open-label extension study in prurigo nodularis will be presented at RAD 2025, reinforcing Nemluvio's rapid impact on key symptoms of atopic dermatitis, and its long-term efficacy in prurigo nodularis.11,12 Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis.9 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional regulatory submissions and reviews are ongoing. More details on Galderma's scientific presentations at RAD can be found here. About NemluvioNemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.13,14 About atopic dermatitisAtopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.3,15,16 It affects more than 230 million people worldwide.3 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.17 Important Safety InformationIndications: NEMLUVIO® (nemolizumab-ilto) is a prescription medicine used: to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis or AD) in combination with prescription therapies used on the skin (topical) when the eczema is not well controlled by topical therapies alone. It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age. to treat adults with prurigo nodularis. It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age. Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you: are scheduled to receive any vaccination. You should not receive a live vaccine right before or during treatment with NEMLUVIO. are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: Breathing problems or wheezing Swelling of the face, lips, mouth, tongue, or throat Fainting, dizziness, feeling lightheaded Fast pulse Swollen lymph nodes Joint pain Fever Skin rash (red or rough skin) Nausea or vomiting General ill feeling Cramps in your stomach area The most common side effects of NEMLUVIO include: Eczema: headache, joint pain, hives (itchy red rash or wheals), and muscle aches Prurigo Nodularis: headache and skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches) These are not all of the possible side effects of NEMLUVIO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088. Please see full Prescribing Information including Patient Information. About GaldermaGalderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: References Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0 Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286-1 Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi: 10.1016/ Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7:102:adv00830. doi: 10.2340/actadv.v102.3932 Durno N, et al. Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi: 10.1080/09546634.2024.2417966 Penton H, et al. Assessing Response in Atopic Dermatitis: A Systematic Review of the Psychometric Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/ Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025 Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi: 10.1002/cti2.1390 Silverberg JI, et al. Nemolizumab was associated with rapid and significant improvements in itch and sleep in patients with moderate-to-severe atopic dermatitis: Results from two global phase 3 pivotal studies (ARCADIA 1 and ARCADIA 2). Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Yosipovitch G, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025 Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911 Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi:10.7861/clinmed.2021-0257 View source version on Contacts For further information: Christian Marcoux, Communications +41 76 315 26 50 Richard HarbinsonCorporate Communications +41 76 210 60 62 Céline Buguet Franchises and R&D Communications Director +41 76 249 90 87 Emil IvanovHead of Strategy, Investor Relations, and +41 21 642 78 12 Jessica CohenInvestor Relations and Strategy +41 21 642 76 43 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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20-03-2025
- Business
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AMWC 2025: Galderma Pushes the Innovation Frontier With Updates From Its Unparalleled Portfolio Designed to Meet the Needs of the Aesthetic Community
Galderma will present new data from across its portfolio, including findings from the RELAX and EXPRESSION studies on Relfydess® (RelabotulinumtoxinA) highlighting its rapid onset of action as early as day one and sustained high patient satisfaction beyond six months1,2 New in vivo data on Sculptra® (PLLA-SCA), the first proven regenerative biostimulator, will be presented, showing its lower inflammatory response compared to PLLA-GA, which can significantly impact local tissue response and product degradation and therefore may impact the duration of clinical effect3-12 Additionally, results from the first-of-its-kind and largest survey on facial changes associated with medication-driven weight loss will be presented showing many patients would consider aesthetic treatments to address these changes, with biostimulators and dermal fillers the most frequently considered13 Galderma will host a symposium exploring how aesthetic treatments can address facial changes associated with medication-driven weight loss in addition to a second symposium dedicated to achieving the ideal lips with Restylane® Kysse™ In total, Galderma will present 11 e-posters, including additional updates on Restylane, and host two symposia, four Masterclass sessions, five Meet-the-Expert sessions, an experiential lounge and an interactive booth, reinforcing its strong leadership position in Injectable Aesthetics ZUG, Switzerland, March 20, 2025--(BUSINESS WIRE)--Galderma (SWX:GALD) will showcase a strong presence at the 23rd Aesthetic & Anti-Aging Medicine World Congress (AMWC) in Monaco from March 27-29, 2025, with two symposia, four Masterclass sessions, 11 research e-posters, and an experiential Galderma lounge alongside its interactive booth (O2, Hall Ravel) featuring five Meet-the-Expert sessions. This extensive program highlights the breadth of Galderma's leading Injectable Aesthetics portfolio, designed to address the present and future needs of patients and healthcare professionals alike. "With our extensive presence at AMWC 2025, we have a valuable platform to engage with the aesthetics community while showcasing the broadest portfolio in the industry. Through our data presentations and expert-led sessions, we reaffirm our commitment to being a leading force in advancing the field of Injectable Aesthetics and equipping healthcare professionals with the innovative solutions they need to fulfill the needs of patients, today and tomorrow." BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA Expert perspectives on the hottest topics in injectable aesthetics today Rates of medication-driven weight loss have increased rapidly in recent years and can be associated with alterations in facial aesthetic appearance of variable magnitude.14 In the largest study investigating facial changes in medication-driven weight loss to date, Galderma surveyed more than 1,300 people across five countries.13 Findings from this first-of-its kind study will be presented, showing 93% of those undergoing weight loss treatment noticed some degree of facial changes during their treatment and many patients are considering aesthetic treatments to address these, with biostimulators and dermal fillers being the most frequently considered treatments.13 The Galderma-sponsored "Medication-Driven Weight Loss: The Algorithms" symposium taking place on Thursday, March 27, as well as a dedicated Masterclass session on Friday, March 28, will explore the effects medication-driven weight loss can have on the face and dive into the ways aesthetic procedures can help restore facial volume and structure. The symposium will feature live demonstrations and expert insights from Dr. Luiz Avelar, Dr. Priyanka Chadha, Prof. Sebastian Cotofana, Dr. Sabrina Fabi, Dr. Marcus Morais, and Dr. Andreas Nikolis. Galderma will also host the "GAIN Experts Dialogue: Defining the Ideal Lips" symposium on Thursday, March 27, featuring expert speakers Prof. Sebastian Cotofana, Dr. Simone Doreian, Dr. Stephanie Lam, Dr. Christoph Martschin, and Dr. Andrei Metelitsa. This session, through insightful debates, cultural and anatomical discussions, and live injection demonstrations, will explore the evolving techniques in aesthetic lip treatments as well as patient standards and preferences for natural looking and feeling results. A Masterclass session will also be held to dive deeper into these techniques on Saturday, March 29. New data cements the unique ability of Galderma's products to meet patient needs Galderma will present new data from the phase IIIb EXPRESSION and RELAX studies, showing Relfydess achieved rapid onset of action and significant aesthetic improvement in frown lines and crow's feet.1,2 In the EXPRESSION study more than 50% of patients reported visible effects as early as day one and, in the RELAX study, effects were sustained through six months, confirming results seen in the READY trial program and more than a third saw improvement beyond six months in frown lines.1,2 Both studies re-confirmed high patient satisfaction with Relfydess, with 70% of patients in the RELAX study reporting that they preferred treatment with Relfydess versus prior treatments received.1,2 Encore data from a post-hoc analysis of the phase III READY program will show that, regardless of baseline wrinkle severity (moderate/severe), subjects treated with Relfydess achieved high rates of improvement in frown lines and crow's feet, along with improved well-being, and a sustained effect through six months.15 Galderma will also present new data on Sculptra (PLLA-SCA), the first proven regenerative biostimulator, reinforcing its unique formulation, efficacy, and safety.3-12 New in vivo comparative data will demonstrate its favorable tissue response and slower, controlled product degradation profile at 52 weeks, as well as lower inflammation, compared to PLLA-GA.11 The lower inflammation is consistent with Sculptra's well-established safety profile.3 Differences in formulation can significantly impact local tissue response and product degradation, affecting potential clinical outcomes such as efficacy and duration.11 An expert consensus also confirms Sculptra's key role in the regenerative aesthetic field and additional data will show its synergistic effect when paired with Alastin®, underscoring its effect across all three skin layers.12,16 Encore data to be presented on Restylane Shaype™, powered by Galderma's proprietary NASHA HD™ Technology and approved in Canada and most recently in Brazil, will show that it constitutes a breakthrough innovation in hyaluronic acid fillers as the firmest hyaluronic acid injectable available and displaying the highest G-prime (indicating superior gel strength and firmness) on the market providing a unique bone mimicking effect.17,18 Additional pooled and pivotal phase IV data to be presented will show that Restylane fillers preserve or enhance the natural expressions of 98% of patients while achieving desired aesthetic improvements in attractiveness and youthfulness.19 This naturalness, combined with high patient satisfaction, represents long-lasting aesthetic improvement.19 To date, Restylane is the first and only hyaluronic acid filler to have in vivo data demonstrating its efficacy in restoring and maintaining the naturalness of expression.19-22 These e-posters, along with others presented on Dysport® and Alastin, will reinforce Galderma's strong dedication to equipping practitioners with the products they need to achieve natural, long-lasting results for their patients. More details on Galderma's scientific presentations at AMWC can be found here. Media can watch this video to find out more about facial changes associated with medication-driven weight loss and this video to learn more about the natural looking results of Restylane products. About Relfydess (RelabotulinumtoxinA) Pioneered by Galderma, Relfydess is the first and only ready-to-use liquid neuromodulator created with PEARL™ Technology that is designed to preserve molecule integrity.23 PEARL Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months.24-27 Relfydess is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.23,28 It was entirely created and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. Relfydess received a marketing authorization in several markets. RelabotulinumtoxinA is an investigational drug product in the U.S. Authorization conditions may vary internationally. About the Restylane Portfolio Restylane hyaluronic acid (HA) injectables are Designed Differently to go beyond volumizing for natural-looking results.29-32 Our HA is exceptionally pure, making it the closest to the skin's own.33 Our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose. Restylane unique technologies, NASHA HD™, NASHA® and OBT™ are meaningfully designed to mimic the diverse range of facial structures and skin layers.29-31 With the Highest G' and Highest flexibility, Restylane can provide from structural support to natural expression to a healthy glow.17,30,33-36 Trusted for almost three decades, our HA gels work in sync with your skin for 100% natural looking results.22,29,37 About Sculptra Sculptra is the first proven regenerative biostimulator, with a unique PLLA-SCA™ formulation that helps restore the deep, underlying structure of the skin by inducing a foreign body reaction.3,48-10,38-47 Sculptra works to address the underlying causes of facial aging, including degradation of the extracellular matrix, which results in volume loss, laxity, and the appearance of wrinkles.3,41,45-47 Sculptra encourages the remodeling of components of the extracellular matrix, such as elastin and collagen, helping to gradually restore facial volume and the look of fullness to wrinkles and folds over time.48-51 The results from Sculptra are long-lasting, with optimal correction seen in approximately three months and results lasting up to two years.4,46,7,52 About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: References Shridharani S, Coquis-knezek S and Prygova I. Aesthetic improvement and rapid results in glabellar and lateral canthal lines after treatment with the innovative liquid relabotulinumtoxinA formulation. Presented at AMWC 2025; Mar 27-29, 2025; Monaco Ablon G, et al. Subject preference and satisfaction with liquid relabotulinumtoxinA treatment of glabellar lines over 12 months, in a randomized controlled trial. Presented at AMWC 2025; Mar 27-29, 2025; Monaco Galderma. Sculptra EU Instructions For Use 2023 Widgegrowl J, et al. A randomized, comparative study describing the gene signatures of poly-l-lactic acid (PLLA-SCA) and calcium hydroxylapaptite (CaHA) in the treatment of nasolabial folds). IMCAS Poster 2024. Paris, France Galderma. Data on file. MA-50526. 43USSA1812 clinical study report. Fort Worth, TX: Galderma Laboratories, L.P. 2022 Bohnert K, et al. Randomized, Controlled, Multicentered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid for Improving Skin Quality. Dermatol Surg 2019;45:718–724 Hexsel D, et al. Introducing the L-Lift—A Novel Approach to Treat Age-Related Facial Skin Ptosis Using A Collagen Stimulator. Dermatol Surg: Letters & Communications. 2019 Galderma. Data on File (MA-60875) Zhang Y, et al. In vivo inducing collagen regeneration of biodegradable polymer microspheres. Regen Biomater. 2021;8(5):rbab042. doi: 10.1093/rb/rbab042 Huth S, et al. Molecular Insights into the effects of PLLA_SCA on Gene Expression. J Drugs Dermatol. 2024;23(4):285-288. doi: 10.36849/JDD.7791 Avelar L, et al. Comparing two biostimulators on the local tissue response and degradation up to 52 weeks in vivo with an indirect comparison to clinical outcomes. Presented at AMWC 2025; Mar 27-29, 2025; Monaco Fabi S, et al. Regenerative aesthetic effects of poly L-lactic acid (PLLA-SCA) treatment. Presented at AMWC 2025; Mar 27-29, 2025; Monaco Nikolis A, Prygova I and Brasatar D. The potential role of biostimulators/dermal fillers to address the impact of medication driven weight loss management treatments on facial appearance. Presented at AMWC 2025; Mar 27-29, 2025; Monaco Humphrey CD & Lawrence AC. Implications of Ozempic and other GLP-1 receptor agonists for facial plastic surgeons. Facial Plast Surg. 2023;39:719-721 Ablon G, et al. RelaBoNT-A treatment of glabellar lines and lateral canthal lines of different baseline severity: subgroup analyses of pooled Phase III study data. Presented at AMWC 2025; Mar 27-29, 2025; Monaco Markowitz O, et al. Evaluation of synergistic effects for midface improvement when pairing Sculptra® (PLLA-SCA) with Alastin skincare®: A comparative study. Abstract presented at AMWC 2025; Mar 27-29, 2025; Monaco Bromée T, et al. A new hyaluronic acid injectable, HASHA, sets new G-prime standards. Abstract presented at AMWC 2025; Mar 27-29, 2025; Monaco Nikolis A, et al. Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion. J Drugs Dermatol. 2024;23(4):255–61. doi: 10.36849/JDD.8145 Nkolis A, et al. Hyaluronic acid fillers preserve natural movement and dynamic expression: data from three postmarketing clinical studies. Presented at AMWC 2025; Mar 27-29, 2025; Monaco Percec, I et al. An Objective, Quantitative, Dynamic Assessment of Hyaluronic Acid Fillers That Adapt to Facial Movement. Plast Reconstr Surg. 2020;145:295e–305e. doi: 10.1097/PRS.0000000000006461 Philipp-Dormston WG, et al. Evaluating Perceived Naturalness of Facial Expression After Fillers to the Nasolabial Folds and Lower Face With Standardized Video and Photography. Dermatol Surg. 2018;44(6):826–32. doi: 10.1097/DSS.0000000000001419 Solish N, et al. Dynamics of hyaluronic acid fillers formulated to maintain natural facial expression. J Cosmet Dermatol. 2019;18(3):738–46. doi: 10.1111/jocd.12961 Sundberg AL and Stahl U. Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) - relabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA Shridharani SM, et al. Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. ASJ. 2024; sjae131 Ablon G, et al. Efficacy and Safety of RelabotulinumtoxinA Liquid Botulinum Toxin in the Treatment of Lateral Canthal Lines: Results From the Phase 3 READY-2 Study. Dermatol Surg. 2024. doi: 10.1097/DSS.0000000000004470 Relfydess®. EU Summary of Product Characteristics Persson C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin Di Gregorio C. 25+ Years of Experience with the Restylane Portfolio of Injectable Hyaluronic Acid Fillers for Facial Aesthetic Treatment. E-poster presented at AMWC, March 27-29, 2024, Monaco Nikolis A, et al. The Role of Clinical Examination in Midface Volume Correction Using Hyaluronic Acid Fillers: Should Patients Be Stratified by Skin Thickness? Aesthet Surg J Open Forum. 2020; 2(1):1–12. Galderma. Data on file. Subject satisfaction (GAIS) – NASHA and OBT Fillers. 2021 Restylane U.S. Instructions For Use. Available online. Accessed January 2025. Kablik J, et al. Comparative Physical Properties of Hyaluronic Acid Dermal Fillers: Dermatologic Surgery 35, 302–312 (2009). Narins RS, et al. Persistence of nasolabial fold correction with a hyaluronic acid dermal filler with retreatment: results of an 18-month extension study. Dermatol Surg. 2011;37:644–650 Talarico S, et al. High Patient Satisfaction of a Hyaluronic Acid Filler Producing Enduring Full-Facial Volume Restoration: An 18-Month Open Multicenter Study. Dermatol Surg. 2015;41:1361–1369 Ohrlund A, et al.. Differentiation of NASHA and OBT Hyaluronic Acid Gels According to Strength, Flexibility, and Associated Clinical Significance. JDD. 2024; 23(1), pp.1332-1336 Philipp‐Dormston WG, et al. Perceived naturalness of facial expression after hyaluronic acid filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19(7):1600-6. U.S. Food and Drug Administration. Sculptra summary of safety and effectiveness data. Available online. Accessed January 2025. Galderma. Data on File (MA-46589) Duracinsky M, et al. Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients. BMC Infect Dis. 2014;14(474). doi:10.1186/1471233414474 Zhang S and Duan E. Fighting against Skin Aging: The Way from Bench to Bedside. Cell Transpl. 2018;27(5):729-738. doi: 10.1177/0963689717725755 Asius J, et al. Inventors. US patent US 7,731,758 B2.2010. Available online. Accessed January 2025 Morgan P, et al. Product Manufacturing Process for Poly-L-lactic acid (PLLA-SCA). Poster presented at IMCAS World Congress, January 26–28, 2023, Paris, France Galderma. Data on File (MA-53568) Shuster S, et al. The influence of age and sex on skin thickness, skin collagen and density. Br J Dermatol. 1975;93(6):639-43. doi: 10.1111/ Goldberg D, et al. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39:915–22 Zarbafian M, et al. The emerging field of regenerative aesthetics—where we are now. Dermatol Surg. 2022;48: 101–108. doi: 10.1097/DSS.0000000000003239 Waibel J, et al. Gene Analysis of Biostimulators: PLLA-SCA Triggers Regenerative Morphogenesis while CaHA-R Induces Inflammation upon Facial Injection. Poster presented at ASDS 2024, October 17-20, 2024, Orlando, Florida, United States Waibel J, et al. Bulk RNA-seq Analysis of Poly-L-Lactic Acid (PLLA-SCA) vs Calcium Hydroxyapetite (CaHA-R) Reveals a Novel, Adipocyte Mediated Regenerative Mechanism of Action Unique to PLLA. Poster presented at ASDS 2024 Annual Meeting, October 17-20, 2024, Orlando, Florida, United States Haddad S, et al. Evaluation of the biostimulatory effects and the level of neocollagenesis of dermal fillers: a review. Int J Dermatol. 2022;61:1284–1288. doi: 10.1111/ijd.16229 Vleggaar D, et al. Consensus recommendations on the use of injectable poly-L-lactic-acid for facial and nonfacial volumization. J Drugs Dermatol. 2014;13(4 Suppl):s44–s51 Fabi S, et al. 24-month clinical trial data on effectiveness and safety after correction of cheek wrinkles using a biostimulatory poly-L-lactic acid injectable implant. Poster presented at AMWC, March 30 - April 1, 2023, Monaco View source version on Contacts For further information: Christian Marcoux, Communications +41 76 315 26 50 Sébastien CrosCorporate Communications +41 79 529 59 85 Emil IvanovHead of Strategy, Investor Relations, and +41 21 642 78 12 Jessica CohenInvestor Relations and Strategy +41 21 642 76 43 Sign in to access your portfolio
