The impact of this matter on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. For more information, please visit our website at https://www.astellas.com/en. Contacts. What is the technology utilized in the development of Fezolinetant (ESN364)? 5Freeman EW, Sammel MD, Sanders RJ. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science intoVALUE for patients. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. Follow us on Twitter at@TheEndoSocietyand@EndoMedia. Women were enrolled at over 180 sites within the U.S.,CanadaandEurope. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. Feb 19, 2021. 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. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. For more information, please visit our website at https://www.astellas.com/en. Health Qual Life Outcomes. Study on Fezolinetant shows encouraging results on women with VMS 3 Fraser GL, Hoveyda HR, Clarke IJ, et al. The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant Colleen Williams 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. 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. 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. About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 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. [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. The trial is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. [4][5], Fezolinetant shows high affinity for and potent inhibition of the NK3 receptor in vitro (Ki = 25nM, IC50 = 20nM). Joanne Fagg. The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). Published: Aug. 18, 2022 at 2:30 a.m. Product name : Fezolinetant Catalog No. The analysis comprised 484 women (fezolinetant 30mg n=166, fezolinetant 45mg n=167, placebo/fezolinetant 30mg n=76, placebo/fezolinetant 45mg n=75). The report also highlights the drug research and development activity details across the United States, Europe and Japan.
