Phone: (202)-971-3655 Endocrinology. Endocrinology. 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. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. Astellas gets safety win for phase 3 menopause drug, setting up US, EU Hot flashes can interrupt a woman's daily life. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. If you do not want us and our partners to use cookies and personal data for these additional purposes, click 'Reject all'. 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. 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 NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Feb-23. A treatment for moderate to severe vasomotor symptoms (VMS) has been accepted by the European Medicines Agency (EMA) for regulatory review. Aug 18 . 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.7,8,9. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. For U.S./CAN Toll Free Call 1-800-526-8630 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. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. For more information, please visit our website at https://www.astellas.com/en. 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 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. Elaborated details on regulatory milestones and other development activities have been provided in this report. Astellas acquired fezolinetant for 500 million euros upfront in 2017. 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. Faslodex | European Medicines Agency 2014;13:203-11. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. 5Freeman EW, Sammel MD, Sanders RJ. 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. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1,2 In the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition and, worldwide, more than half of women 40 to 64 years of age experience VMS.3,4,5,6 VMS can have a disruptive impact on women's daily activities and overall quality of life.1. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. 3Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. Women were enrolled at over 180 sites within the U.S.,CanadaandEurope. 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. [2], In March 2023, results from SKYLIGHT 1, a Phase III clinical study of the treatment of moderate to severe hot flashes due to menopause were published in The Lancet. 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). The impact of this matter on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. 1 Depypere H, Timmerman D, Donders G, et al. J Clin Endocrinol Metab. Astellas are not responsible for the information or services on this site. Send a Release; ALL CONTACT INFO; Contact Us. 2020;27:382-92. 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. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. A detailed picture of the Fezolinetant (ESN364) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2020-2030 is provided in this report along with a detailed description of the product. Menopause. Health Qual Life Outcomes. For media inquiries and reporter requests, please click here to fill out a request form. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2. Published: Aug. 18, 2022 at 2:30 a.m. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Fezolinetant | C16H15FN6OS - PubChem Fezolinetant (ESN364) is a Neurokinin 3 receptor antagonists under development for the treatment of Vasomotor symptoms. 6Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Granger AL, Fehnel SE, et al. : 1629229-37-3 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses : Laboratory chemicals, manufacture of substances. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. Product name : Fezolinetant Catalog No. 2014;21:924-932. 2019;104:5893-5905. 4th ed. It is being developed by Astellas. Faslodex can only be obtained with a prescription. If you would like to customise your choices, click 'Manage privacy settings'. 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. BREAKING: Fezolinetant news - Hotflash Inc 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. 2020;27:382-92. :20220818fezolinetant-VMS . [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. Fezolinetant in Hot Flashes - Clinical Trials Registry - ICH GCP Pooled analyses will also be presented from SKYLIGHT 1 and SKYLIGHT 2 . J ClinEndocrinol Metab. 888-776-0942 from 8 AM - 10 PM ET. 2014;21:924-932. The MarketWatch News Department was not involved in the creation of this content. 5Freeman EW, Sammel MD, Sanders RJ. Col 2, para 1, lines 4-6. 2005;3:47. Phone: (202)-971-3611 Jan 3, 2023 06:30am. Select one or more newsletters to continue. 3Fraser GL, Hoveyda HR, Clarke IJ, 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. 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 study being presented Saturday at ENDO 2022, the Endocrine Societys annual meeting in Atlanta, Ga. Senior Communications Manager, Public Relations, Director, Communications and Media Relations. Adis is an information provider. 2020;27:382-392. Menopause. Endocrinology. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant"issued on August 18, 2022. 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. 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. Read about our historyand how we continue to serve the endocrine community. Bayer extends elinzanetant trials to include breast cancer Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. The website you are about to visit is not owned or controlled by Astellas. Active ingredients. Application type. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. What is the forecasted market scenario of Fezolinetant (ESN364)? 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. 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. 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 media inquiries and reporter requests, please click here to fill out a request form. Astellas Provides Update on Fezolinetant New Drug Application in U.S. 2015;156:4214-25. For media inquiries and reporter requests, please click here to fill out a request form. 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. 3Fraser GL, Hoveyda HR, Clarke IJ, et al. The Institute for Clinical and Economic Review stated fezolinetant's evidence is rated as promising but inconclusive to determine whether fezolinetant provides a net health benefit for patients over the long term; however, using point estimates from short-term clinical trials, analyses suggest this drug would achieve common thresholds for cost-effectiveness if priced between $2,000 . [2] Phase IIa trials in polycystic ovary syndrome patients are ongoing. 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. . 2015;156:4214-4225. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Genevieve Neal-Perry, MD, PhD, discusses her research on fezolinetant as a treatment for hot flashes. Phase III SKYLIGHT 4 trial of ESN 364 meets the primary endpoint in Fezolinetant in Hot Flashes - Clinical Trials Registry - ICH GCP Phase 3 study finds fezolinetant reduces the frequency and severity of menopausal hot flashes. Faslodex is available as a solution for injection in prefilled syringes (250 mg). Atlanta, GA June 11, 2022. About FezolinetantFezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Elinzanetant - Wikipedia 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.