For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. For the co-primary endpoint of reduction in mean frequency of moderate to severe VMS versus placebo, fezolinetant 30 mg demonstrated a -1.82 (p=<0.001) and -1.86 (p=<0.001) mean change per day at . For more information, please visit our website at https://www.astellas.com/en. News | Astellas Pharma Inc. Fezolinetant is an oral, nonhormonal therapy that works by blocking neurokinin B (NKB) binding on the KNDy neuron to moderate neuronal activity in the hypothalamus to reduce the frequency and severity of symptoms associated with menopause. 2Fraser GL, Lederman S, Waldbaum A, et al. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. Randomisation was double-blind and the randomisation number was assigned based on information obtained from Interactive Response If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. At week 12, fezolinetant significantly reduced total VMS score vs placebo (-26.5 vs -12.2, P < 0.001) and decreased mean frequency of moderate/severe VMSs by five episodes per day vs placebo. Fezolinetant significantly reduced the frequency and severity of moderate-to-severe vasomotor symptoms (VMS), or hot flashes, associated with menopause, according to a Phase 3 industry-sponsored . To learn more about the Society and the field of endocrinology, visit our site atwww.endocrine.org. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science intoVALUE for patients. J ClinEndocrinol Metab. The MarketWatch News Department was not involved in the creation of this content. Ogeda announces fezolinetant as INN and issuance of U.S. The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. Select one or more newsletters to continue. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. 2006;96:1226-1235. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Menopause. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Fezolinetant: The New Non-Hormonal Medication Being Studied for Hot 1 Depypere H, Timmerman D, Donders G, et al. 2015;156:4214-25. Astellas are not responsible for the information or services on this site. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Women were enrolled at over 180 sites within the U.S.,CanadaandEurope. Fezolinetant (ESN364) Clinical Assessment. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. For more information, please visit our website at https://www.astellas.com/en. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. Treatment for: Menopausal Disorders, Hot Flashes. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. "We remain confident in the clinical profile of fezolinetant and the potential benefits it could bring to women experiencing moderate to severe VMS due to menopause, and we will continue to work with the FDA on its review of the NDA for fezolinetant," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. 4 bWomen aged 40-65 years with a minimum average of 7 moderate-to-severe hot flashes per day were randomised to once-daily exact-matched placebo, fezolinetant 30 mg, or fezolinetant 45 mg (ratio 1:1:1). Genevieve Neal-Perry, MD, PhD, discusses her research on fezolinetant as a treatment for hot flashes. BREAKING: Fezolinetant news - Hotflash Inc Neurokinin Receptor Antagonist, Fezolinetant, for Treatment of Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor . This website is intended for U.S. residents only. Astellas' eyes filings for menopause drug fezolinetant after ph3 win 4th ed. A detailed description of regulatory milestones, development activities, and some key findings provide the current development scenario of Fezolinetant (ESN364). News | Astellas Pharma Inc. What is the product type, route of administration and mechanism of action of Fezolinetant (ESN364)? Please read our privacy policy for more information on the cookies we use, the processing of your personal data and how to delete or block the use of cookies. [1] [2] 2017 5 I . Waltham, MA: Elsevier, 2014. About FezolinetantFezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Health Qual Life Outcomes. TOKYO, February 19, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline results from the Phase 3 pivotal SKYLIGHT 1 and SKYLIGHT 2 clinical trials for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of . The NDA is supported by results from the BRIGHT SKY program, which included three Phase 3 clinical trials that collectively enrolled over 2,800 women with VMS across the U.S., Canada and Europe. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. Astellas to Present Fezolinetant 12-Week Findings from Phase 3 SKYLIGHT This website contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, or in different dosages. The companies and academics are working to assess challenges and seek opportunities that could influence Fezolinetant (ESN364) dominance. 1Utian WH. "We remain confident in the clinical profile of fezolinetant and the potential benefits it could bring to women experiencing moderate to severe VMS due to menopause, and we will continue to work with the FDA on its review of the NDA for fezolinetant," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. The Endocrine Society is the worlds oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. By using this site, you accept our use of cookies as described in our privacy policy. You can change your choices at any time by clicking on the 'Privacy dashboard' links on our sites and apps. By using this site, you accept our use of cookies as described in our privacy policy. Joanne Fagg. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Menopause. 2015;156:4214-4225. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. . Regarding AT132, we submitted a series of responses to clinical hold by FDA by -- in March. Astellas Provides Update on Fezolinetant New Drug Application in U.S. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Astellas Provides Update on Fezolinetant New Drug Application in U.S. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Astellas was notified on February 17, 2023, that the FDA is extending the PDUFA goal date by three months, to May 22, 2023, to allow more time to complete their review. There were several high-profile approvals last month, including for Apellis's Syfovre, given a broad label and a flexible dosing regimen in geographic atrophy. The therapies under development are focused on novel approaches to treat/improve the disease condition. FDA to Review NDA for Nonhormonal Therapy for Menopause Results from the SKYLIGHT 1 and SKYLIGHT 2 pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause. Fezolinetant reduced moderate/severe VMS by about 62% to 81% at week 4, depending on dose, compared with about a 39% reduction with placebo. TOKYO, Feb. 19, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the U.S. Food and Drug Administration (FDA) notified the company that it is extending the original priority review Prescription Drug User Fee Act (PDUFA) goal date for fezolinetant, an investigational agent for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. 3Fraser GL, Hoveyda HR, Clarke IJ, et al. About FezolinetantFezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. Fezolinetant is under clinical development by Astellas Pharma and currently in the Pre-Registration in clinical pathway. This website contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, or in different dosages. Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. . EP3428168A1 - Deuterated fezolinetant - Google Patents Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. Elaborated details on regulatory milestones and other development activities have been provided in this report. Astellas Submits Fezolinetant New Drug Application to U.S. FDA The safety and efficacy of fezolinetant are under investigation and have not been established. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.3,4,7 The safety and efficacy of fezolinetant are under investigation and have not been established. Sorry, you need to enable JavaScript to visit this website. Fezolinetant (ESN364) Analytical Perspective, In-depth Fezolinetant (ESN364) Market Assessment. Fezolinetant | C16H15FN6OS - PubChem The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). Feb-23. Astellas gets safety win for phase 3 menopause drug, setting up US, EU Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. 2014;21:924-932. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. Climacteric. This website provides access to information from Astellas sponsored clinical trials and the purpose is not to promote or advertise any Read about our latest progress around our Corporate Strategic Plan. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant, For further information: Astellas Portfolio Communications: Anna Otten, +1 (847) 682-4812, anna.otten@astellas.com; Astellas Pharma Inc. Corporate Advocacy & Relations: +81-3-3244-3201, California Declaration of Comprehensive Compliance Program, Vermonts Pharmaceutical Marketer Price Disclosure, Wholesale Acquisition Cost Information for Colorado Prescribers, Consumer Product Safety Commission Regulations, Understanding the Gastric and GEJ Cancer Landscape. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant"issued on August 18, 2022. Comprehensive coverage of the late-stage emerging therapies (Phase III) for Vasomotor symptoms. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS due to menopause.1,2,3 The safety and efficacy of fezolinetant are under investigation and have not been established. Endocrine Society is a global community of physicians and scientists dedicated to accelerating scientific breakthroughs and improving patient health and well being. fezolinetant - . Fezolinetant - Ogeda Alternative Names: A2693; AS3472693-00; ESN-364 Latest Information Update: 15 Mar 2023. Astellas are not responsible for the information or services on this site. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. VMS is characterized by hot flushes and/or night sweats which are . The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderates levels of ovarian hormones throughout the menstrual cycle. ET. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements.