Latest news with #Lundbeck
Mint
18-07-2025
- Health
- Mint
Otsuka, Lundbeck's PTSD Drug Fails to Win US FDA Panel Support
Otsuka Pharmaceutical Co.'s medicine for post-traumatic stress disorder with partner H. Lundbeck A/S failed to win the backing of US regulatory advisers, a major setback in the drugmakers' bid to bring the first new drug for the condition to market in more than two decades. The panel of external advisers to the Food and Drug Administration voted 10-to-1 on Friday that the efficacy of the companies' brexpiprazole tablets marketed under the brand name Rexulti — in combination with sertraline — hadn't been established. Panelists struggled to make sense of Otsuka and Lundbeck's supporting evidence, which included one successful study and one in which combining Rexulti with sertraline showed no effect on the symptoms of PTSD. 'I'm looking at these studies and I'm just not convinced the combination offers me as a clinician a new tool in the toolbox,' said Murray Raskind, a psychiatrist at the University of Washington. The Psychopharmacologic Drugs Advisory Committee's recommendations aren't binding, but are often followed by the agency. FDA Commissioner Marty Makary has repeatedly mentioned PTSD as a condition for which new medicines are needed, specifically for veterans. 'We owe it to that community to review some of the potential therapeutics and get a decision out without any delays,' he said in June. The drugmakers have been seeking to broaden the approved usage of brexpiprazole, which is currently cleared for treating schizophrenia in adults and adolescents, as well as an an adjunctive therapy to antidepressants in adults with major depressive disorder. In 2023, the FDA also approved brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer's disease. The drug was discovered by Otsuka, and the Japanese drugmaker is co-developing it with Lundbeck. Post-traumatic stress disorder or PTSD affects about 5% of the population in the US in a given year, according to the companies. It can develop after life-threatening or traumatic events and only two medications — sertraline and paroxetine — are approved in the US to treat it. The drugs' response rates rarely exceed 60%, and fewer than 30% of patients experience full remission, according to the FDA. This article was generated from an automated news agency feed without modifications to text.
Bloomberg
18-07-2025
- Health
- Bloomberg
Otsuka, Lundbeck's PTSD Drug Fails to Win US FDA Panel Support
Otsuka Pharmaceutical Co. 's medicine for post-traumatic stress disorder with partner H. Lundbeck A/S failed to win the backing of US regulatory advisers, a major setback in the drugmakers' bid to bring the first new drug for the condition to market in more than two decades. The panel of external advisers to the Food and Drug Administration voted 10-to-1 on Friday that the efficacy of the companies' brexpiprazole tablets marketed under the brand name Rexulti — in combination with sertraline — hadn't been established.
Yahoo
24-06-2025
- Health
- Yahoo
Lundbeck receives orphan drug designation in the US and EU for Lu AG13909 for the treatment of patients with congenital adrenal hyperplasia
Congenital adrenal hyperplasia (CAH) is a rare autosomal recessive disease1 with an estimated global incidence of approximately 1 in 14,000–18,000 live births2 A phase II trial has recently been initiated to investigate the efficacy and safety of LuAG13909 for the potential treatment of CAH3 VALBY, Denmark, June 24, 2025 /PRNewswire/ -- Lundbeck today announces that orphan drug designation has been granted to Lu AG13909 by the US Food and Drug Administration (FDA) on 12 May 2025 and the European Medicines Agency (EMA) on 20 June 2025. Lu AG13909 is a novel, humanised monoclonal antibody, under investigation for the treatment of patients with CAH, a rare genetic disease. CAH is characterised by impaired cortisol production and elevated levels of adrenocorticotropic hormone (ACTH), a hormone produced in the brain and involved in the regulation of multiple functions in the body. Elevated levels of ACTH lead to additional adrenal hormone imbalance, ultimately resulting in multiple developmental disturbances including symptoms related to the central nervous system, and long-term health concerns. "CAH is a life-long condition, requiring constant management. Many existing treatments focus on controlling cortisol levels, however these options are often complicated by side effects. The orphan drug designation for Lu AG13909, our potential first in class anti-ACTH antibody, reflects the program's innovative approach, as well as the high medical need to find new treatments for CAH," said Johan Luthman, EVP and Head of Research and Development at Lundbeck. Lu AG13909 is advancing to mid-stage clinical development, as a new therapeutic approach for conditions marked by elevated ACTH levels, such as CAH. Lundbeck is currently expanding an ongoing Phase I/II clinical open-label trial, evaluating the efficacy and safety of anti-ACTH antibody Lu AG13909 in adults with classic CAH. The trial will open for enrolment in North America and seven countries across Europe, with the first sites opening in late June 2025. The expanded trial will enrol men and women, aged ≥18 to ≤70 years with classic CAH, under stable glucocorticoid dosing. Participants will receive monthly intravenous administrations of Lu AG13909 and will be divided into two cohorts. The first will include participants with hyperandrogenemia, and the second will include participants with normal androgen levels, but treated with supraphysiologic glucocorticoid doses. Participants may enter an optional open-label extension, where they receive monthly Lu AG13909 administration over a period of 12 months. About Lu AG13909Lu AG13909 is a humanised anti-ACTH monoclonal antibody that specifically recognises ACTH with high affinity. It blocks the binding of ACTH to the melanocortin 2 receptor in the adrenal glands and thereby inhibits the neurohormonal signalling of ACTH. This inhibition causes a decreased secretion of glucocorticoids, mineralocorticoids and androgens from the adrenal glands.3,4 ACTH plays a key role in the biosynthesis of adrenal steroids5 and is therefore considered a promising therapeutic target in conditions characterised by elevated ACTH levels.4 In this context, Lu AG13909, a novel molecule, may provide a therapeutic approach for treating conditions associated with chronically elevated ACTH levels. In animal studies, Lu AG13909 has shown significant and durable reductions of corticosterone/cortisol and aldosterone.3 No adverse effects were observed after 6 months of intravenous dosing. About congenital adrenal hyperplasiaClassic CAH is a rare, autosomal recessive disorder1 affecting 1 in 14,000–18,000 live births worldwide.2 Classic CAH is characterised by an enzyme deficiency, most commonly 21-hydroxylase deficiency, affecting the adrenal steroidogenesis leading to cortisol and aldosterone deficiency. People with 21-hydroxylase deficiency are at risk of adrenal crisis, a life-threatening condition contributing to the increased mortality throughout life.6 Balancing physiological glucocorticoid replacement and control of hyperandrogenism remains a challenge with the risk of long-term consequences of glucocorticoid overtreatment.7-9 Contacts Marie Petterson Jens Høyer Head of Media Relations, Corp. Communication Vice President, Head of Investor Relations MEEP@ JSHR@ +45 29 82 21 82 +45 30 83 45 01Palle Holm OlesenVice President, Investor RelationsPALO@ 30 83 24 26 About H. Lundbeck A/SLundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site and connect with us via LinkedIn. References: Merke DP, Auchus RJ. N Engl J Med 2020;383(13):1248-61 Claahsen-van der Grinten HL, et al. Endocr Rev 2022;43(1):91-159 Lundbeck. Data on file Feldhaus AL, et al. Endocrinology 2017;158(1):1-8 Xing Y, et al. J Endocrinol 2011;209(3):327-35 Lousada LM, et al. Arch Endocrinol Metab 2021;65(4):488-94 Han TS, et al. Nat Rev Endocrinol 2014;10(2):115-24 Pofi R, et al. Clin Endocrinol (Oxf) 2023 Auchus RJ, et al. Front Endocrinol (Lausanne) 2022;13:1005963 CONTACT: H. Lundbeck A/SOttiliavej 9, 2500 Valby, Denmark+45 3630 1311info@ This information was brought to you by Cision The following files are available for download: ACTH ODD Press release_Final View original content: SOURCE H. Lundbeck A/S Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
24-06-2025
- Health
- Yahoo
Lundbeck receives orphan drug designation in the US and EU for Lu AG13909 for the treatment of patients with congenital adrenal hyperplasia
Congenital adrenal hyperplasia (CAH) is a rare autosomal recessive disease1 with an estimated global incidence of approximately 1 in 14,000–18,000 live births2 A phase II trial has recently been initiated to investigate the efficacy and safety of LuAG13909 for the potential treatment of CAH3 VALBY, Denmark, June 24, 2025 /PRNewswire/ -- Lundbeck today announces that orphan drug designation has been granted to Lu AG13909 by the US Food and Drug Administration (FDA) on 12 May 2025 and the European Medicines Agency (EMA) on 20 June 2025. Lu AG13909 is a novel, humanised monoclonal antibody, under investigation for the treatment of patients with CAH, a rare genetic disease. CAH is characterised by impaired cortisol production and elevated levels of adrenocorticotropic hormone (ACTH), a hormone produced in the brain and involved in the regulation of multiple functions in the body. Elevated levels of ACTH lead to additional adrenal hormone imbalance, ultimately resulting in multiple developmental disturbances including symptoms related to the central nervous system, and long-term health concerns. "CAH is a life-long condition, requiring constant management. Many existing treatments focus on controlling cortisol levels, however these options are often complicated by side effects. The orphan drug designation for Lu AG13909, our potential first in class anti-ACTH antibody, reflects the program's innovative approach, as well as the high medical need to find new treatments for CAH," said Johan Luthman, EVP and Head of Research and Development at Lundbeck. Lu AG13909 is advancing to mid-stage clinical development, as a new therapeutic approach for conditions marked by elevated ACTH levels, such as CAH. Lundbeck is currently expanding an ongoing Phase I/II clinical open-label trial, evaluating the efficacy and safety of anti-ACTH antibody Lu AG13909 in adults with classic CAH. The trial will open for enrolment in North America and seven countries across Europe, with the first sites opening in late June 2025. The expanded trial will enrol men and women, aged ≥18 to ≤70 years with classic CAH, under stable glucocorticoid dosing. Participants will receive monthly intravenous administrations of Lu AG13909 and will be divided into two cohorts. The first will include participants with hyperandrogenemia, and the second will include participants with normal androgen levels, but treated with supraphysiologic glucocorticoid doses. Participants may enter an optional open-label extension, where they receive monthly Lu AG13909 administration over a period of 12 months. About Lu AG13909Lu AG13909 is a humanised anti-ACTH monoclonal antibody that specifically recognises ACTH with high affinity. It blocks the binding of ACTH to the melanocortin 2 receptor in the adrenal glands and thereby inhibits the neurohormonal signalling of ACTH. This inhibition causes a decreased secretion of glucocorticoids, mineralocorticoids and androgens from the adrenal glands.3,4 ACTH plays a key role in the biosynthesis of adrenal steroids5 and is therefore considered a promising therapeutic target in conditions characterised by elevated ACTH levels.4 In this context, Lu AG13909, a novel molecule, may provide a therapeutic approach for treating conditions associated with chronically elevated ACTH levels. In animal studies, Lu AG13909 has shown significant and durable reductions of corticosterone/cortisol and aldosterone.3 No adverse effects were observed after 6 months of intravenous dosing. About congenital adrenal hyperplasiaClassic CAH is a rare, autosomal recessive disorder1 affecting 1 in 14,000–18,000 live births worldwide.2 Classic CAH is characterised by an enzyme deficiency, most commonly 21-hydroxylase deficiency, affecting the adrenal steroidogenesis leading to cortisol and aldosterone deficiency. People with 21-hydroxylase deficiency are at risk of adrenal crisis, a life-threatening condition contributing to the increased mortality throughout life.6 Balancing physiological glucocorticoid replacement and control of hyperandrogenism remains a challenge with the risk of long-term consequences of glucocorticoid overtreatment.7-9 Contacts Marie Petterson Jens Høyer Head of Media Relations, Corp. Communication Vice President, Head of Investor Relations MEEP@ JSHR@ +45 29 82 21 82 +45 30 83 45 01Palle Holm OlesenVice President, Investor RelationsPALO@ 30 83 24 26 About H. Lundbeck A/SLundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site and connect with us via LinkedIn. References: Merke DP, Auchus RJ. N Engl J Med 2020;383(13):1248-61 Claahsen-van der Grinten HL, et al. Endocr Rev 2022;43(1):91-159 Lundbeck. Data on file Feldhaus AL, et al. Endocrinology 2017;158(1):1-8 Xing Y, et al. J Endocrinol 2011;209(3):327-35 Lousada LM, et al. Arch Endocrinol Metab 2021;65(4):488-94 Han TS, et al. Nat Rev Endocrinol 2014;10(2):115-24 Pofi R, et al. Clin Endocrinol (Oxf) 2023 Auchus RJ, et al. Front Endocrinol (Lausanne) 2022;13:1005963 CONTACT: H. Lundbeck A/SOttiliavej 9, 2500 Valby, Denmark+45 3630 1311info@ This information was brought to you by Cision The following files are available for download: ACTH ODD Press release_Final View original content: SOURCE H. Lundbeck A/S Sign in to access your portfolio
Yahoo
21-06-2025
- Health
- Yahoo
New data from phase III trial confirms efficacy of Vyepti® (eptinezumab) in Asian population with chronic migraine
The full results of the phase III registrational SUNRISE trial were presented at the European Academy of Neurology 2025 Annual Congress, where eptinezumab demonstrated statistically significant reductions in mean monthly migraine days (MMDs) compared with placebo1 Patients receiving eptinezumab were four times more likely to achieve a reduction of ≥75% in MMDs within the first 4 weeks, compared to placebo1 The SUNRISE trial met all key secondary efficacy endpoints with improvements seen as early as day 1 and sustained through week 121 VALBY, Denmark, June 21, 2025 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) today announced the full results from the SUNRISE trial, a randomized, placebo-controlled trial designed to evaluate the efficacy and safety of eptinezumab versus placebo in a predominantly Asian population with chronic migraine. The study was presented at the 11th Congress of the European Academy of Neurology taking place in Helsinki 21-24 June.1 "Various treatments are recommended for patients with migraine in Asia, however utilization and adherence to migraine-specific treatment is relatively low. Access to effective treatments remains a significant unmet medical need for migraine prevention in Asia" said Johan Luthman, EVP and Head of R&D at Lundbeck. "The data from SUNRISE is consistent with previous results across diverse populations and will be pivotal for our efforts to expand access to eptinezumab for patients in Asia suffering with severe migraine." The double-blind, pivotal, SUNRISE trial (n=983) met all key primary and secondary endpoints, with eptinezumab demonstrating greater reductions in migraine frequency, the proportion of migraine attacks with severe pain, and disease burden, compared to placebo.1 "The SUNRISE trial marks a significant step forward in the mission to make migraine-specific preventive treatments more globally accessible, ensuring that patients with severe migraine receive the care they need" said Dr Patricia Pozo-Rosich, Head of Section of the Neurology Department, Director of Headache and Craniofacial Pain Clinical Unit and the Migraine Adaptive Brain Center at the Vall d'Hebron University Hospital in Barcelona, and principal investigator in the SUNRISE trial. In the SUNRISE trial, patients receiving eptinezumab experienced significantly fewer monthly migraine days (MMDs), with eptinezumab offering a -7.5 (300 mg) and -7.2 (100 mg) reduction in MMDs from week 1 through to 12, versus -4.8 with placebo (baseline MMD = 17, p<0.0001 for both 300 mg and 100 mg vs placebo).1 Amongst other parameters, patients receiving eptinezumab (300 mg or 100 mg) were four times more likely to achieve a reduction of ≥75% in the number of migraine days per month, compared to placebo within the first 4 weeks (p<0.0001).1 In the same study, eptinezumab also demonstrated a rapid onset of preventive efficacy, where more participants reported being free of migraine as early as day 1 after receiving eptinezumab treatment compared to placebo (p<0.002 for 300 mg dose; p<0.01 for 100 mg dose). This clinical efficacy was also reflected in patient reported outcomes where patients reported clinically meaningful improvements which were greater with eptinezumab than with placebo.1 Finally, the safety profile of eptinezumab was generally similar to placebo, previous trials, and to the current labelled safety information in the United States prescribing information and EU Summary of Product Characteristics, with the most common treatment-emergent adverse events being COVID-19 and nasopharyngitis.1 Based on the SUNRISE results, Lundbeck has initiated discussions with relevant regulatory authorities with the aim of making eptinezumab available for people suffering from migraine across Asia. About migraine Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound. Not only is headache painful, but migraine also imposes both a social and financial burden. Migraine has a profound impact on patient functioning including relationships with family/friends, leisure activities, household production and worker productivity. Migraine is one of the most prevalent neurological diseases for which medical treatment is sought, and worldwide, is considered the leading cause of disability for people under the age of 50 and the 2nd leading cause of disability worldwide.3,4 Repeated headache attacks, and often the constant fear of the next one, damage family life, social life and work life. Furthermore, frequent use of acute migraine treatments may leave patients experiencing, or at risk of developing, medication overuse headache. Despite equally high prevalence of migraine in Asia as compared western countries, significant unmet needs remain in terms of sufficient and appropriate diagnosis, and better management and therapies for treatment of migraine in East Asia.5 In China, an estimated 14.3% of adults are living with migraine. From this population, approximately 52.9% will visit hospitals and only 13.8% of them will be diagnosed with migraine.6 About the SUNRISE trial SUNRISE (NCT04921384) is an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled phase III trial, to confirm the efficacy and safety of eptinezumab in participants with chronic migraine who are eligible for preventive treatment.2 The study was conducted to support marketing authorization across Asia. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days. Participants were randomly allocated to one of three treatment groups: eptinezumab 300 mg, eptinezumab 100 mg, or placebo. The double-blind, placebo-controlled treatment period was followed by an extension period where all participants received active treatment to further assess the safety and tolerability of eptinezumab. The total trial duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Extension Period (12 weeks), and a Safety Follow-up Period (8 weeks).1 Participants in Japan completing the SUNRISE trial were offered to continue in the SUNSET trial (NCT05064371) which consisted of an open-label eptinezumab treatment of 60 weeks (five infusions), and a Safety Follow-up Period (8 weeks). The SUNRISE was initiated in May 2021 and was conducted in Mainland China, Georgia, Japan, Poland, Slovakia, South Korea, Spain and Taiwan. In the trial, 983 participants were randomized to receive eptinezumab 100 mg or 300 mg or placebo by intravenous (IV) infusion.2 About Vyepti® (eptinezumab) Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was intentionally designed for IV administration. The efficacy and safety of eptinezumab was evaluated in two phase III clinical trials (PROMISE-1 in episodic migraine7 and PROMISE-2 in chronic migraine8), where eptinezumab met its primary endpoint of decrease in MMDs over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of eptinezumab as early as day 1 post-infusion. The safety of eptinezumab was evaluated in more than 2,000 adult patients with migraine who received at least one dose of eptinezumab. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with eptinezumab discontinued treatment due to adverse reactions. Vyepti® (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month. Today, eptinezumab is launched in more than 30 markets worldwide. Contacts Marie Petterson Jens Høyer Head of Media Relations, Corp. Communication Vice President, Head of Investor Relations MEEP@ JSHR@ +45 29 82 21 82 +45 30 83 45 01Palle Holm OlesenVice President, Investor RelationsPALO@ 30 83 24 26 About H. Lundbeck A/S Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site and connect with us via LinkedIn. References: Yu S, ePresentation at EAN Congress 2025 H. Lundbeck A/S. Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine (Sunrise). NCT04921384 Steiner TJ, Stovner LJ, Vos T. et al. J Headache Pain 2018; 19: 17. Leonardi M, Steiner TJ, Scher AT, Lipton RB. J Headache Pain. 2005; 6(6): 429– 440. Takeshima, T, et al. J Headache Pain 2019; 20, 111 Guidelines for the diagnosis and treatment of migraine in China (2022 edition). Chinese Journal of Pain Medicine 2022, 28 (12) Ashina M, et al. Cephalalgia. 2020 Mar;40(3):241-254. Lipton RB, et al. Neurology. 2020 Mar 31;94(13):e1365-e1377. CONTACT: H. Lundbeck A/SOttiliavej 9, 2500 Valby, Denmark+45 3630 1311info@ This information was brought to you by Cision The following files are available for download: EAN 2025 Press Release SUNRISE_Final View original content:
