Latest news with #MichelleHorn
Yahoo
4 days ago
- Business
- Yahoo
GSK makes new drug submission for depemokimab in Canada
GSK has made a new drug submission (NDS) to Health Canada for the monoclonal antibody, depemokimab, targeting two specific conditions. The first proposed indication is for the use as an add-on maintenance treatment for asthma in individuals aged 12 years and above with type 2 inflammation marked by an eosinophilic phenotype. The second is for treating adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Depemokimab targets interleukin-5 (IL-5), which plays a crucial role in type 2 inflammation. GSK's submission is supported by the positive Phase III SWIFT and ANCHOR trial data. These trials have demonstrated that the antibody could provide sustained inhibition of a key disease driver and assist in achieving clinical outcomes with two injections annually. The extended half-life and binding affinity of the antibody support a dosing regimen of a single injection every six months. Patients with CRSwNP often suffer from symptoms such as loss of smell, facial pain, nasal obstruction, sleep disturbance, nasal discharge and infections. The effectiveness and safety of the antibody are still being investigated, and it has neither been granted any authorisation nor approved for use in any nation at present. GSK Canada country medical director Michelle Horn stated: 'The combined submission for asthma and CRSwNP marks a significant step toward addressing the unmet needs of patients. 'Backed by strong clinical evidence, depemokimab has the potential to become the first ultra-long-acting biologic offering patients sustained inhibition of IL-5, a key driver of their disease with twice-yearly dosing, and represents a promising advancement for patients and physicians alike.' In November 2024, GSK secured Health Canada's approval for Ojjaara (momelotinib) to treat myelofibrosis in adults with moderate-to-severe anaemia. "GSK makes new drug submission for depemokimab in Canada" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Cision Canada
5 days ago
- Health
- Cision Canada
GSK's depemokimab accepted for review by Health Canada for the treatment of asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps
SWIFT-1 and -2 trials showed depemokimab reduced exacerbation and hospitalization rates as an add-on therapy for patients with asthma with type 2 inflammation versus placebo ANCHOR-1 and -2 trials showed early and sustained reductions in nasal polyp size and nasal obstruction versus placebo for patients with chronic rhinosinusitis with nasal polyps Across the SWIFT and ANCHOR clinical trials, the overall incidence and severity of treatment-emergent adverse events were similar in patients treated with either depemokimab or placebo If approved, depemokimab will be the first ultra-long-acting biologic with two doses per year (6-month dosing) MISSISSAUGA, ON, May 26, 2025 /CNW/ - GSK has submitted a New Drug Submission (NDS) to Health Canada for depemokimab for two proposed indications: The first indication is as an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller. The second indication is as an add-on maintenance treatment of adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The NDS is based on data from the positive SWIFT and ANCHOR trials. Michelle Horn, Country Medical Director, GSK Canada, said: "The combined submission for asthma and CRSwNP marks a significant step toward addressing the unmet needs of patients. Backed by strong clinical evidence, depemokimab has the potential to become the first ultra-long-acting biologic offering patients sustained inhibition of IL-5, a key driver of their disease with twice-yearly dosing, and represents a promising advancement for patients and physicians alike." Depemokimab, a monoclonal antibody that targets IL-5, is the first ultra-long-acting biologic to be evaluated in phase III trials. 1, 2, 3 IL-5 is a key cytokine (protein) in type 2 inflammation. 1, 5, 6 Type 2 inflammation is typically identified by blood eosinophil count and is an underlying driver in many diseases. This type of inflammation is present in the majority of patients with difficult to treat asthma and can lead to exacerbations and hospitalization. 5, 6, 7 Type 2 inflammation is also present in up to 85% of people with CRSwNP and is associated with more severe disease and symptoms. 8, 9, 10, 11, 12 With IL-5 inhibition, eosinophils are significantly reduced and there is evidence to show IL-5 has broader effects on other structural and immune cell types beyond eosinophils. 5, 6, 22, 23, 24, 25, 26 In patients with asthma with type 2 inflammation and patients with CRSwNP, the SWIFT and ANCHOR trials, respectively, met their primary endpoints, showing that depemokimab could offer sustained inhibition of an important driver of their disease, and help achieve key clinical outcomes with a dosing schedule of just two injections per year. 1, 2, 3 Depemokimab's extended half-life, high-binding affinity and potency, support a dosing regimen of one injection every six months (26 weeks).. 1, 2, 3 As demonstrated in studies of other diseases, longer intervals between doses have been shown to overcome barriers to optimal care, such as patient adherence, and can reduce the burden of disease for patients. 4 In Canada, more than 4.7 million people are currently affected by asthma, a chronic and sometimes debilitating condition. 27 Many Canadian asthmatics continue to experience symptoms such as difficulty breathing and chest tightness, despite treatment with high-dose inhaled corticosteroids plus a second controller (and/or systemic corticosteroids). 5,20 People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being. 8, 9, 10, 11 Such symptoms mean the impact of CRSwNP on overall quality of life has been reported to be comparable with other chronic diseases such as COPD, asthma, and diabetes. 9 The safety and effectiveness of depemokimab are still under investigation and authorization has not yet been granted. Depemokimab is currently not approved for use in any country. About SWIFT-1 and SWIFT-2 SWIFT-1 and SWIFT-2 were replicate 52-week, randomised (2:1), double-blind, placebo-controlled, parallel-group, multi-centre Phase III clinical trials. 1 The trials assessed the efficacy and safety of depemokimab as adjunctive therapy in 382 and 380 participants with severe asthma with type 2 inflammation characterised by blood eosinophil count, including adult and adolescent patients, who were randomised to receive depemokimab or a placebo respectively, in addition to their standard of care treatment with medium to high-dose inhaled corticosteroids plus at least one additional controller. 1 In each trial, the rate of asthma exacerbations was significantly lower in the depemokimab group than in the placebo group. 1 These results have been reported and published in the New England Journal of Medicin e. 1 About ANCHOR-1 and ANCHOR-2 ANCHOR-1 and ANCHOR-2 were replicate 52-week, randomised (1:1), double-blind, placebo-controlled, parallel-group, multi-centre Phase III clinical trials. 2, 3 The trials assessed the efficacy and safety of depemokimab as add-on therapy to standard of care in 271 and 257 adult patients with CRSwNP inadequately controlled on intranasal corticosteroids. 2, 3 The co-primary endpoints were met with statistically significant reductions in nasal polyp size and nasal obstruction in patients receiving depemokimab versus placebo, at 52 weeks. 2, 3 Full results of ANCHOR-1 and ANCHOR-2 have been reported and published in The Lancet. 19 About GSK in respiratory GSK is redefining the future of respiratory medicine as it builds on decades of pioneering work to deliver more ambitious treatment goals and develop the next-generation standard of care, for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics, and inhaled medicines, we are focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood diseases like refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease progression. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025. 1. Jackson DJ, et al. Six Monthly Depemokimab in Severe Asthma With an Eosinophilic Phenotype. NEJM. Published on September 9 at 2. Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-1) Available at: Accessed February 2025 3. Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2) Available at: Accessed February 2025 4. Scarsi KK, Swindells S. The Promise of Improved Adherence With Long-Acting Antiretroviral Therapy: What Are the Data? Journal of the International Association of Providers of AIDS Care (JIAPAC). 2021;20. 5. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention,2024. Updated May 2024. Available at: Accessed February 2025. 6. Heaney L, et al. Eosinophilic and Noneosinophilic Asthma: An Expert Consensus Framework to Characterize Phenotypes in a Global Real-Life Severe Asthma Cohort. Chest. 2021;160(3):814-830. 7. Principe S, et al. Severe asthma: Targeting the IL-5 pathway. Clin Exp Allergy. 2021 Aug;51(8):992-1005 8. Laidlaw TM, et al. Chronic Rhinosinusitis with Nasal Polyps and Asthma. J. Allergy Clin. Immunol. 2001;9(3):1133-1141. 9. Bachert C, et al. Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps. J Asthma Allergy. 2021;b 11;14:127-134. 10. De Corso E, et al. How to manage recurrences after surgery in CRSwNP patients in the biologic era: a narrative review. Acta Otorhinolaryngol Ital. 2023;43(Suppl. 1):S3-S13. 11. Chen S, et al. Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med Res Opin. 2020;36(11):1897-1911. 12. Bachert C, et al. EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management. J Allergy Clin Immunol. 2021;147(1):29-36. 13. American Lung Association. Severe Asthma. Available at: Accessed February 2025. 14. American Lung Association. Asthma Trends and Burden. Available at: Accessed February 2025. 15. An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103) (AGILE). Available at: Accessed February 2025. 16. A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (NIMBLE). Available at: Accessed February 2025. 17. Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) Available at: Accessed February 2025. 18. Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (DESTINY) Available at: Accessed February 2025. 19. Gevaert P, et al. Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase III, randomised, double-blind, parallel trials. The Lancet. Published on February 28 at 20. World Health Organisation. Asthma Key Facts. Available at: Accessed February 2025 21. Israel, E, et al. Severe and Difficult-to-Treat Asthma in Adults. N Engl J Med 2017;377:965-76. 22. Buchheit KM, et al. Mepolizumab targets multiple immune cells in aspirin-exacerbated respiratory disease. J Allergy Clin Immunol. 2021;148(2):574-584. 23. Barretto KT, et al. Human airway epithelial cells express a functional IL-5 receptor. Allergy. 2020;75(8):2127-2130. 24. Bajbouj K, et al. IL-5 receptor expression in lung fibroblasts: Potential role in airway remodelling in asthma. Allergy. 2023;78(3):882-885. 25. Siddiqui S, et al. Eosinophils and tissue remodeling: Relevance to airway disease. J Allergy Clin Immunol. 2023;152(4):841-857. 26. Bergantini L, et al. Regulatory T cell monitoring in severe eosinophilic asthma patients treated with mepolizumab. Scand J Immunol. 2021;94(1):e13031. SOURCE GlaxoSmithKline Inc.
Yahoo
5 days ago
- Health
- Yahoo
GSK's depemokimab accepted for review by Health Canada for the treatment of asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps
SWIFT-1 and -2 trials showed depemokimab reduced exacerbation and hospitalization rates as an add-on therapy for patients with asthma with type 2 inflammation versus placebo ANCHOR-1 and -2 trials showed early and sustained reductions in nasal polyp size and nasal obstruction versus placebo for patients with chronic rhinosinusitis with nasal polyps Across the SWIFT and ANCHOR clinical trials, the overall incidence and severity of treatment-emergent adverse events were similar in patients treated with either depemokimab or placebo If approved, depemokimab will be the first ultra-long-acting biologic with two doses per year (6-month dosing) MISSISSAUGA, ON, May 26, 2025 /CNW/ - GSK has submitted a New Drug Submission (NDS) to Health Canada for depemokimab for two proposed indications: The first indication is as an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller. The second indication is as an add-on maintenance treatment of adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The NDS is based on data from the positive SWIFT and ANCHOR trials. Michelle Horn, Country Medical Director, GSK Canada, said: "The combined submission for asthma and CRSwNP marks a significant step toward addressing the unmet needs of patients. Backed by strong clinical evidence, depemokimab has the potential to become the first ultra-long-acting biologic offering patients sustained inhibition of IL-5, a key driver of their disease with twice-yearly dosing, and represents a promising advancement for patients and physicians alike." Depemokimab, a monoclonal antibody that targets IL-5, is the first ultra-long-acting biologic to be evaluated in phase III trials.1,2,3 IL-5 is a key cytokine (protein) in type 2 inflammation.1,5,6 Type 2 inflammation is typically identified by blood eosinophil count and is an underlying driver in many diseases. This type of inflammation is present in the majority of patients with difficult to treat asthma and can lead to exacerbations and hospitalization.5,6,7 Type 2 inflammation is also present in up to 85% of people with CRSwNP and is associated with more severe disease and symptoms.8,9,10,11,12 With IL-5 inhibition, eosinophils are significantly reduced and there is evidence to show IL-5 has broader effects on other structural and immune cell types beyond eosinophils.5,6,22,23,24,25,26 In patients with asthma with type 2 inflammation and patients with CRSwNP, the SWIFT and ANCHOR trials, respectively, met their primary endpoints, showing that depemokimab could offer sustained inhibition of an important driver of their disease, and help achieve key clinical outcomes with a dosing schedule of just two injections per year.1,2,3 Depemokimab's extended half-life, high-binding affinity and potency, support a dosing regimen of one injection every six months (26 weeks)..1,2,3 As demonstrated in studies of other diseases, longer intervals between doses have been shown to overcome barriers to optimal care, such as patient adherence, and can reduce the burden of disease for patients.4 In Canada, more than 4.7 million people are currently affected by asthma, a chronic and sometimes debilitating condition.27 Many Canadian asthmatics continue to experience symptoms such as difficulty breathing and chest tightness, despite treatment with high-dose inhaled corticosteroids plus a second controller (and/or systemic corticosteroids). 5,20 People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.8,9,10,11 Such symptoms mean the impact of CRSwNP on overall quality of life has been reported to be comparable with other chronic diseases such as COPD, asthma, and diabetes.9 The safety and effectiveness of depemokimab are still under investigation and authorization has not yet been granted. Depemokimab is currently not approved for use in any country. About SWIFT-1 and SWIFT-2SWIFT-1 and SWIFT-2 were replicate 52-week, randomised (2:1), double-blind, placebo-controlled, parallel-group, multi-centre Phase III clinical trials.1 The trials assessed the efficacy and safety of depemokimab as adjunctive therapy in 382 and 380 participants with severe asthma with type 2 inflammation characterised by blood eosinophil count, including adult and adolescent patients, who were randomised to receive depemokimab or a placebo respectively, in addition to their standard of care treatment with medium to high-dose inhaled corticosteroids plus at least one additional controller.1 In each trial, the rate of asthma exacerbations was significantly lower in the depemokimab group than in the placebo group. 1 These results have been reported and published in the New England Journal of Medicine.1 About ANCHOR-1 and ANCHOR-2ANCHOR-1 and ANCHOR-2 were replicate 52-week, randomised (1:1), double-blind, placebo-controlled, parallel-group, multi-centre Phase III clinical trials. 2,3 The trials assessed the efficacy and safety of depemokimab as add-on therapy to standard of care in 271 and 257 adult patients with CRSwNP inadequately controlled on intranasal corticosteroids.2,3 The co-primary endpoints were met with statistically significant reductions in nasal polyp size and nasal obstruction in patients receiving depemokimab versus placebo, at 52 weeks. 2,3 Full results of ANCHOR-1 and ANCHOR-2 have been reported and published in The Lancet.19 About GSK in respiratoryGSK is redefining the future of respiratory medicine as it builds on decades of pioneering work to deliver more ambitious treatment goals and develop the next-generation standard of care, for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics, and inhaled medicines, we are focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood diseases like refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease progression. About GSKGSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statementsGSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025. References 1. Jackson DJ, et al. Six Monthly Depemokimab in Severe Asthma With an Eosinophilic Phenotype. NEJM. Published on September 9 at 2. Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-1) Available at: Accessed February 2025 3. Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2) Available at: Accessed February 2025 4. Scarsi KK, Swindells S. The Promise of Improved Adherence With Long-Acting Antiretroviral Therapy: What Are the Data? Journal of the International Association of Providers of AIDS Care (JIAPAC). 2021;20. 5. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention,2024. Updated May 2024. Available at: Accessed February 2025. 6. Heaney L, et al. Eosinophilic and Noneosinophilic Asthma: An Expert Consensus Framework to Characterize Phenotypes in a Global Real-Life Severe Asthma Cohort. Chest. 2021;160(3):814-830. 7. Principe S, et al. Severe asthma: Targeting the IL-5 pathway. Clin Exp Allergy. 2021 Aug;51(8):992-1005 8. Laidlaw TM, et al. Chronic Rhinosinusitis with Nasal Polyps and Asthma. J. Allergy Clin. Immunol. 2001;9(3):1133-1141. 9. Bachert C, et al. Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps. J Asthma Allergy. 2021;b 11;14:127-134. 10. De Corso E, et al. How to manage recurrences after surgery in CRSwNP patients in the biologic era: a narrative review. Acta Otorhinolaryngol Ital. 2023;43(Suppl. 1):S3-S13. 11. Chen S, et al. Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med Res Opin. 2020;36(11):1897-1911. 12. Bachert C, et al. EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management. J Allergy Clin Immunol. 2021;147(1):29-36. 13. American Lung Association. Severe Asthma. Available at: Accessed February 2025. 14. American Lung Association. Asthma Trends and Burden. Available at: Accessed February 2025. 15. An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103) (AGILE). Available at: Accessed February 2025. 16. A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (NIMBLE). Available at: Accessed February 2025. 17. Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) Available at: Accessed February 2025. 18. Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (DESTINY) Available at: Accessed February 2025. 19. Gevaert P, et al. Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase III, randomised, double-blind, parallel trials. The Lancet. Published on February 28 at 20. World Health Organisation. Asthma Key Facts. Available at: Accessed February 2025 21. Israel, E, et al. Severe and Difficult-to-Treat Asthma in Adults. N Engl J Med 2017;377:965-76. 22. Buchheit KM, et al. Mepolizumab targets multiple immune cells in aspirin-exacerbated respiratory disease. J Allergy Clin Immunol. 2021;148(2):574-584. 23. Barretto KT, et al. Human airway epithelial cells express a functional IL-5 receptor. Allergy. 2020;75(8):2127-2130. 24. Bajbouj K, et al. IL-5 receptor expression in lung fibroblasts: Potential role in airway remodelling in asthma. Allergy. 2023;78(3):882-885. 25. Siddiqui S, et al. Eosinophils and tissue remodeling: Relevance to airway disease. J Allergy Clin Immunol. 2023;152(4):841-857. 26. Bergantini L, et al. Regulatory T cell monitoring in severe eosinophilic asthma patients treated with mepolizumab. Scand J Immunol. 2021;94(1):e13031. 27. Public Health Agency of Canada. (2024). Canadian Chronic Disease Surveillance System (CCDSS) Data Tool. Retrieved from SOURCE GlaxoSmithKline Inc. View original content to download multimedia: 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
