2020;27:382-392. The NDA submission is based on results from two pivotal Phase 3 clinical trials, SKYLIGHT 1and SKYLIGHT 2, and the Phase 3 long-term safety study, SKYLIGHT 4. Detailed results will be submitted for publication and for consideration at upcoming medical meetings. 2 Jones RE, Lopez KH, eds. 7Depypere H, Timmerman D, Donders G, Sieprath P, Ramael S, Combalbert J, et al. 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 . Bayer extends elinzanetant trials to include breast cancer "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 . Cision Distribution 888-776-0942 Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Phone: (202)-971-3611 Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. 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 recommended dose is 500 mg given once a month, with an additional 500-mg dose two weeks after the first dose. Menopause. Treatment of Menopausal Vasomotor Symptoms With Fezolinetant - PubMed News | Astellas Pharma Inc. The topline data further characterize the long-term safety profile of fezolinetant and will inform future regulatory filings. Sorry, you need to enable JavaScript to visit this website. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. [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. Menopause. For more information, please visit our website at https://www.astellas.com/en. J ClinEndocrinol Metab. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. 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. For GMT Office Hours Call +353-1-416-8900, Internet Explorer presents a security risk. Within the NDA, Astellas proposes a 45 mg daily dose, which is subject to the FDA's review. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. 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. . 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. Proposed indication. 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. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. 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. Colleen Williams "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 . Published: Aug. 18, 2022 at 2:30 a.m. [emailprotected], Jenni Glenn Gingery Overview. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Women were enrolled at over 180 sites within the U.S.,CanadaandEurope. Menopause. Read about our historyand how we continue to serve the endocrine community. 1 Utian WH. Any information on the products contained herein is not intended to provide medical advice nor should be used as a substitute for the advice provided by your physician or other healthcare provider. 4th ed. Menopause. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. OR06-5 Fezolinetant for Treatment of Moderate-to-severe Vasomotor 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. 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. Fezolinetant: A Non-Hormonal Treatment for Hot Flashes Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. Astellas are not responsible for the information or services on this site. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant Astellas gets safety win for phase 3 menopause drug, setting up US, EU M.D., senior vice president and head of development therapeutic areas at Astellas, said in a press release. Astellas Announces Topline 12-week Results from Phase 3 Study of Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science intoVALUE for patients. 1 Depypere H, Timmerman D, Donders G, et al. 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. 3Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. Menopause, a normal part of aging, is the time of a woman's last period. [6][7], Unlike GnRH modulators, but similarly to estrogens, NK3 receptor antagonists including fezolinetant and MLE-4901 (also known as AZD-4901, formerly AZD-2624) have been found to alleviate hot flashes in menopausal women. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. 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. About Fezolinetant VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1,2. Phase 3 study finds fezolinetant reduces the frequency and severity of menopausal hot flashes. It is being developed by Astellas. 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. Endocrine Society is a global community of physicians and scientists dedicated to accelerating scientific breakthroughs and improving patient health and well being.