Astellas' eyes filings for menopause drug fezolinetant after ph3 win Fezolinetant Reduces Vasomotor Symptoms in Menopause Menopause. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. The study treatments are fezolinetant 30 mg (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. This study was for women in menopause with moderate to severe hot flashes. Phase III SKYLIGHT 4 trial of ESN 364 meets the primary endpoint in In 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. Health Qual Life Outcomes. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Senior Communications Manager, Public Relations 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. 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. 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. 2008;11:32-43. Fezolinetant is an investigational oral . [emailprotected], Jenni Glenn Gingery 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 . 1Utian WH. 2005;3:47. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. Published: Aug. 18, 2022 at 2:30 a.m. 2008;11:32-43. [3] Loss-of-function mutations in TACR and TACR3, the genes respectively encoding neurokinin B and its receptor, the NK3 receptor, have been found in patients with idiopathic hypogonadotropic hypogonadism. DUBLIN--(BUSINESS WIRE)--The "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering. 2015;156:4214-25. from 8 AM - 9 PM ET. 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. The PDUFA target action date is Feb. 22, 2023, following use of a priority review voucher. 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. Climacteric. Fezolinetant: The New Non-Hormonal Medication Being Studied for Hot Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 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. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 3Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. 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. 4Gold EB, Colvin A, Avis N, et al. PDF Safety Data Sheet [1] [2] 2017 5 I . A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant, Astellas Submits Fezolinetant New Drug Application to U.S. FDA. 2020;27:382-392. Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030 The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. "Based on our initial assessment, we are pleased with the outcome of the SKYLIGHT 4 study, which further characterizes the long-term safety of fezolinetant," said Nancy Martin, M.D., PharmD, Vice President, Global Medical Head, Medical Specialties, Astellas. Astellas Pharma Inc., submitted a marketing authorization application (MAA) for fezolinetant, an investigational oral, nonhormonal compound. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Severity and frequency of moderate/severe VMSs were reduced from the first day of treatment. What are the other emerging products available and how these are giving competition to Fezolinetant (ESN364)? Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. 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. The dose is given as two injections, each given into the muscle of one buttock over one to two minutes. About Fezolinetant [4][5], Fezolinetant shows high affinity for and potent inhibition of the NK3 receptor in vitro (Ki = 25nM, IC50 = 20nM). Neurokinin Receptor Antagonist, Fezolinetant, for Treatment of Fezolinetant Shows Positive Response in Vasomotor Symptoms Associated Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The report also features the SWOT analysis with analyst insights and key findings of Fezolinetant (ESN364). It is developed by Astellas Pharma which acquired it from Ogeda (formerly Euroscreen) in April 2017. OR06-5 Fezolinetant for Treatment of Moderate-to-severe Vasomotor Price : $50 * Buy Profile. 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. . The companies and academics are working to assess challenges and seek opportunities that could influence Fezolinetant (ESN364) dominance. 7 Fraser GL, Hoveyda HR, Clarke IJ, et al. The study's primary objectives were to evaluate the effect offezolinetanton endometrial health and the long-term safety and tolerability of fezolinetant. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1,2. By using this site, you accept our use of cookies as described in our privacy policy. Fezolinetant: The New Non-Hormonal Medication Being Studied for Hot Flash Reduction // Are you suffering from hot flashes but cannot take estrogen or don't w. Prior art date 2017-07-12 Legal status (The legal status is an assumption and . fezolinetant 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. For more information about this report visit https://www.researchandmarkets.com/r/q7m5ni, ResearchAndMarkets.com For more information, please visit our website at https://www.astellas.com/en. For more information, please visit our website at https://www.astellas.com/en. What is the product type, route of administration and mechanism of action of Fezolinetant (ESN364)? This website is intended for U.S. residents only. 888-776-0942 from 8 AM - 10 PM ET. The study is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. Menopause. Phase 3 study finds fezolinetant reduces the frequency and severity of menopausal hot flashes.