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. 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. Colleen Williams Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. It is being developed by Astellas. NK3!FDA Fezolinetant Astellas to Present Fezolinetant 12-Week Findings from Phase 3 SKYLIGHT VMS is characterized by hot flushes and/or night sweats which are . 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. Phil Taylor. 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. 2015;156:4214-4225. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Which are the late-stage emerging therapies under development for the treatment of Vasomotor symptoms. Hot flashes can interrupt a woman's daily life. With the trio of trials now complete, Astellas says it can press ahead with regulatory filings for the new drug, keeping its nose ahead of its main rival Bayer, which paid $425 million upfront to . 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. 3 Fraser GL, Hoveyda HR, Clarke IJ, et al. Additionally, for the co-primary endpoint of reduction in mean severity of moderate to severe VMS versus placebo, fezolinetant 30 mg demonstrated a -0.15 (p=<0.021) and -0.16 (p=0.049) mean change per day at weeks 4 and 12 . 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. Proposed indication. 5Freeman EW, Sammel MD, Sanders RJ. "I am excited by the potential of a new nonhormonal treatment option for women experiencing moderate to severe VMS associated with menopause.". For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. Fezolinetant: The New Non-Hormonal Medication Being Studied for Hot 6Williams RE, Kalilani L, DiBenedetti DB, et al. 2020;27:382-92. The website you are about to visit is not owned or controlled by Astellas.