2005;3:47. For media inquiries and reporter requests, please click here to fill out a request form. 2019;104:5893-5905. 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. It is being developed by Astellas. Fezolinetant is an antagonist of the GPCR known as the tachykinin NK3 receptor and acts on specific neurons that control body temperature to mimic the effects of estrogen, but in a non-hormonal manner, to directly and safely address the basis for HF in menopausal women. Astellas Announces Topline 12-week Results from Phase 3 Study of U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant, Astellas Submits Fezolinetant New Drug Application to U.S. FDA. Phase 3 study finds fezolinetant reduces the frequency and severity of . ", "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. By using this site, you accept our use of cookies as described in our privacy policy. Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist. press@researchandmarkets.com The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. 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). Further . EP3428168A1 - Deuterated fezolinetant - Google Patents Other emerging products for Vasomotor symptoms are giving market competition to Fezolinetant (ESN364) and launch of late-stage emerging therapies in the near future will significantly impact the market. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2, "In the United States, 60% to 80% of individuals experience VMS during or after the menopausal transition, with limited nonhormonal treatment options," said Ahsan Arozullah,M.D., M.P.H.,Senior Vice President and Head of Development Therapeutic Areas, Astellas. Elinzanetant - Wikipedia Fezolinetant: The New Non-Hormonal Medication Being Studied for Hot Flash Reduction // Are you suffering from hot flashes but cannot take estrogen or don't w. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. This in-depth analysis of the forecasted sales data of Fezolinetant (ESN364) from 2020 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Fezolinetant (ESN364). 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. . There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. The trials are double-blinded and placebo-controlled for the first 12 weeks followed by 40-week active treatment extension period. Astellas Provides Update on Fezolinetant New Drug Application in U.S. [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. 2006;96:1226-1235. Colleen Williams For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. Faslodex is available as a solution for injection in prefilled syringes (250 mg). About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. Astellas Submits Fezolinetant New Drug Application to U.S. FDA About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. At week 12, fezolinetant significantly reduced total VMS score vs placebo (-26.5 vs -12.2, P < 0.001) and decreased mean frequency of moderate/severe VMSs by five episodes per day vs placebo. As Fezolinetant moves closer to clinical approval, what is the 2020;27:382-92. J ClinEndocrinol Metab. About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 2 Jones RE, Lopez KH, eds. Przegl Menopauzalny [Menopause Rev]. TOKYO, Feb. 19, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the U.S. Food and Drug Administration (FDA) notified the company that it is extending the original priority review Prescription Drug User Fee Act (PDUFA) goal date for fezolinetant, an investigational agent for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. What are the other emerging products available and how these are giving competition to Fezolinetant (ESN364)? Feb 19, 2021. For GMT Office Hours Call +353-1-416-8900, Internet Explorer presents a security risk. 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. In the coming years, the market scenario for Vasomotor symptoms is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. 5Freeman EW, Sammel MD, Sanders RJ. A detailed description of regulatory milestones, development activities, and some key findings provide the current development scenario of Fezolinetant (ESN364). If you do not want us and our partners to use cookies and personal data for these additional purposes, click 'Reject all'. Astellas Provides Update on Fezolinetant New Drug Application in U.S. Phil Taylor. Our communications team will respond to verified media requests within 24-48 hours as appropriate. Padcev (enfortumab vedotin) is the first Nectin-4-directed antibody-drug conjugate (ADC) approved for the treatment of advanced urothelial cancer, the most common form of bladder cancer.. 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. Atlanta, GA June 11, 2022. Astellas Provides Update on Fezolinetant New Drug Application in U.S. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. The study was placebo-controlled for 12 weeks followed by a 40-week blinded extension to assess the maintenance of effect. [2] Phase IIa trials in polycystic ovary syndrome patients are ongoing. Col 2, para 1, lines 4-6. Accepted date. Is there anything wrong with this page? Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist. Fezolinetant is under clinical development by Astellas Pharma and currently in the Pre-Registration in clinical pathway. Astellas gets safety win for phase 3 menopause drug, setting up US, EU The primary endpoint assessing endometrial health was achieved and the most common treatment emergent adverse events (TEAE) were headache and COVID-19, consistent with placebo. 2019;104:5893-5905. Which are the late-stage emerging therapies under development for the treatment of Vasomotor symptoms. Viking accuses Chinese biotech of 'ruse' to raid trade secrets and make off with NASH cache. Astellas Provides Update on Fezolinetant New Drug Application in U.S. Climacteric. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. Fezolinetant: The New Non-Hormonal Medication Being Studied for Hot Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. Menopause. Health Qual Life Outcomes. This segment of the report provides forecasted sales data from 2020 to 2030. The report contains forecasted sales for Fezolinetant (ESN364) till 2030. 2005;3:47. Neurokinin Receptor Antagonist, Fezolinetant, for Treatment of 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. Cision Distribution 888-776-0942 VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2. [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 for treatment of moderate-to-severe vasomotor symptoms 4th ed. The recommended dose is 500 mg given once a month, with an additional 500-mg dose two weeks after the first dose. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Human Reproductive Biology. Ogeda announces fezolinetant as INN and issuance of U.S. "The FDA's acceptance of our NDA for fezolinetant brings us one step closer to advancing care for women in the U.S. who experience VMS," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. 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. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. The report also features the SWOT analysis with analyst insights and key findings of Fezolinetant (ESN364). Fezolinetant (ESN364) is a Neurokinin 3 receptor antagonists under development for the treatment of Vasomotor symptoms. 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 more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. Data support the clinical use of fezolinetant as a non-hormonal treatment for vasomotor symptoms associated with menopause. On estime la dure moyenne des SVM 7,4 ans. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. 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. authenticate users, apply security measures, and prevent spam and abuse, and, display personalised ads and content based on interest profiles, measure the effectiveness of personalised ads and content, and, develop and improve our products and services. Fezolinetant is an investigational oral . What is the technology utilized in the development of Fezolinetant (ESN364)? 2008;11:32-43. TOKYO, February 19, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline results from the Phase 3 pivotal SKYLIGHT 1 and SKYLIGHT 2 clinical trials for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of . Fezolinetant is an investigational oral . :20220818fezolinetant-VMS . Emergent, Astellas & More Submit New Applications to FDA What is the history of Fezolinetant (ESN364) and what is its future? Improvements were achieved in all quality-of-life . 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. Astellas to Present Findings from Phase 3 Long-Term Safety Study of . The safety and efficacy of fezolinetant are under investigation and have not been established. Help us improve the Therapeutic Goods Administration site. The impact of this matter on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. About FezolinetantFezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. This website is intended for U.S. residents only. DUBLIN--(BUSINESS WIRE)--The "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering. 2008;11:32-43. 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. "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 fezolinetant," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. 4Gold EB, Colvin A, Avis N, et al. 2014;21:924-932. Joanne Fagg. 2 Fraser GL, Lederman S, Waldbaum A, et al. A treatment for moderate to severe vasomotor symptoms (VMS) has been accepted by the European Medicines Agency (EMA) for regulatory review. About Fezolinetant A (new medicine) Publication date. Fezolinetant - Wikipedia Sorry, you need to enable JavaScript to visit this website. Improvement in VMS frequency and severity observed through week 12 (statistically significant differences vs placebo) was maintained throughout the 52-week total study period for those receiving fezolinetant.