", "Vasomotor symptoms are often reported as the most bothersome symptoms of menopause, yet there has been very little innovation in this therapeutic area," said Genevieve Neal-Perry, M.D., Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynecology. On estime la dure moyenne des SVM 7,4 ans. The website you are about to visit is not owned or controlled by Astellas. 2006;96:1226-1235. TOKYO, June 23, 2022 / PRNewswire / -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced a New Drug Application (NDA) for fezolinetant has been submitted to the U.S. Food and Drug Administration (FDA). News | Astellas Pharma Inc. 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. Am J Public Health. Astellas Provides Update on Fezolinetant New Drug Application in U.S. ResearchAndMarkets.com Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office . 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. Fezolinetant ( INN; former developmental code name ESN-364) is a small-molecule, orally active, selective neurokinin-3 (NK 3) receptor antagonist which is under development by for the treatment of sex hormone -related disorders. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. It is estimated that 60% to 80% of . The companies and academics are working to assess challenges and seek opportunities that could influence Fezolinetant (ESN364) dominance. To ensure the most secure and best overall experience on our website, we recommend the latest versions of, "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030", https://www.researchandmarkets.com/r/q7m5ni. 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 . TOKYO, March 7, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced topline results from the Phase 3 SKYLIGHT 4 clinical trial investigating the long-term safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with .