Cision Distribution 888-776-0942 Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant", Astellas Enters into Definitive Agreement to Acquire Iveric Bio, Results from Astellas' Phase 3 SPOTLIGHT Trial of Investigational Zolbetuximab Published in The Lancet. Atlanta, GA June 11, 2022. Stem-cell based therapy shows promise in treating high-risk type 1 diabetes, COVID-19 vaccination appears to be safe for patients treated for hypothyroidism, Phase 3 study finds fezolinetant reduces the frequency and severity of menopausal hot flashes, Accelerating Breakthroughs & Improving Care. 7Depypere H, Timmerman D, Donders G, Sieprath P, Ramael S, Combalbert J, et al. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. 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. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Help us improve the Therapeutic Goods Administration site. 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. MOONLIGHT 1 is an ongoing randomized Phase 3 clinical trial evaluating the efficacy and safety of fezolinetant in 302 women in China, Korea and Taiwan who take fezolinetant 30 mg QD for 24 weeks . "With these fezolinetant data, we are hopeful that we will have the opportunity to deliver a first-in-class, nonhormonal treatment option for moderate to severe VMS associated with menopause. The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. 2019;104:5893-905. The safety and efficacy of fezolinetant are under investigation and have not been established. By using this site, you accept our use of cookies as described in our privacy policy. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2. About VMS Associated with Menopause VMS, characterized by hot flashes (also called hot flushes) and/or night sweats are common symptoms of menopause.1,2 Worldwide, more than half of women 40 to 64 years of age experience VMS and, in the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition.3,4,5,6VMS can have a disruptive impact on women's daily activities and overall quality of life.1, About FezolinetantFezolinetant is an investigational, oral nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. For more information, please visit our website at https://www.astellas.com/en. Viking accuses Chinese biotech of 'ruse' to raid trade secrets and make off with NASH cache. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. 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. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). For media inquiries and reporter requests, please click here to fill out a request form. 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. The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. 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. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor . Select one or more newsletters to continue. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science intoVALUE for patients. Astellas booked 13.1 billion of amortization of the intangible asset relating to PRV as R&D expense in the first quarter of fiscal year 2022. . Contacts Jean Combalbert: Ruth Devenyns: Chief Executive Officer: Chief Financial Officer +32 71 348 520 +32 71 348 500: info@ogeda.com : info@ogeda.com : Consilium Strategic Communications 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. Detailed results will be submitted for publication and for consideration at upcoming medical meetings. 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. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. This website is intended for U.S. residents only. 2008;11:32-43. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist. The trials are double-blinded and placebo-controlled for the first 12 weeks followed by 40-week active treatment extension period. 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. Senior Communications Manager, Public Relations Other emerging products for Vasomotor symptoms are giving market competition to Fezolinetant (ESN364) and launch of late-stage emerging therapies in the near future will significantly impact the market. Fezolinetant (ESN364) Analytical Perspective, In-depth Fezolinetant (ESN364) Market Assessment. Our communications team will respond to verified media requests within 24-48 hours as appropriate. Fezolinetant (ESN364) Clinical Assessment. If approved by regulatory authorities, fezolinetant would be a first-in-class, nonhormonal treatment option to reduce the frequency and severity of VMS associated with menopause. Proposed indication. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Elinzanetant (developmental code names BAY-3427080 GSK-1144814, NT-814) is an orally active small-molecule neurokinin/tachykinin NK 1 receptor and NK 3 receptor antagonist which is under development by Bayer, GlaxoSmithKline, and NeRRe Therapeutics for the treatment of hot flashes and "sex hormone disorders". There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Comprehensive coverage of the late-stage emerging therapies (Phase III) for Vasomotor symptoms. Feb-23. Hot flashes can interrupt a woman's daily life. [6] As such, they are similar to GnRH modulators, and present as a potential clinical alternative to them for use in the same kinds of indications. Bayer acquired elinzanetant as part of its takeover of UK biotech KaNDy Therapeutics in 2020, while Astellas acquired fezolinetant as part of its 2017 takeover of Ogeda. 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. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. On estime la dure moyenne des SVM 7,4 ans. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. All rights reserved. The study treatments were fezolinetant 30 milligrams (mg) (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of . 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. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor . Accepted date. Menopause. 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.1,2,3The safety and efficacy of fezolinetant are under investigation and have not been established. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. About FezolinetantFezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. 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. Astellas' bid to bring menopause drug candidate fezolinetant to market has hit a last-minute snag. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. . 2019;104:5893-905. The MarketWatch News Department was not involved in the creation of this content. 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. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Menopause. Astellas are not responsible for the information or services on this site. Feb 19, 2021. Health Qual Life Outcomes. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. Astellas acquired fezolinetant for 500 million euros upfront in 2017. Press Releases, Policy Letters and more For 100 years, the Endocrine Society has been at the forefront of hormone science and public health. To learn more about the Society and the field of endocrinology, visit our site atwww.endocrine.org. 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. 2014;13:203-211. 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. Before Seagen's $43 billion deal to be acquired by Pfizer last month, the biotech company had received takeover offers going back to at least 2019, according to a new filing that provides a play . Astellas Provides Update on Fezolinetant New Drug Application in U.S. For further information: Contacts for inquiries or additional information: Astellas Portfolio Communications, Anna Criddle, +1 (847) 682-4812, anna.criddle@astellas.com, Astellas Pharma Inc. Corporate Advocacy & Relations, +81-3-3244-3201. Menopause. Human Reproductive Biology. 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. [3] In accordance, NK3 receptor antagonists like fezolinetant have been found to dose-dependently suppress luteinizing hormone (LH) secretion, though not that of follicle-stimulating hormone (FSH), and consequently to dose-dependently decrease estradiol and progesterone levels in women and testosterone levels in men. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Fezolinetant (INN; former developmental code name ESN-364) is a small-molecule, orally active, selective neurokinin-3 (NK3) receptor antagonist which is under development by for the treatment of sex hormone-related disorders. The website you are about to visit is not owned or controlled by Astellas.
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