Fezolinetant reduced moderate/severe VMS by about 62% to 81% at week 4, depending on dose, compared with about a 39% reduction with placebo. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Our communications team will respond to verified media requests within 24-48 hours as appropriate. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. 2 Jones RE, Lopez KH, eds. Astellas are not responsible for the information or services on this site. 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. "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. 2014;13:203-11. Health Qual Life Outcomes. The Endocrine News podcast brings you the latest research and clinical advances from experts in the field, whether you are in your car, office, or out for a run. Przegl Menopauzalny [Menopause Rev]. Menopause. What is the history of Fezolinetant (ESN364) and what is its future? Astellas are not responsible for the information or services on this site. The impact of this matter on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155)and SKYLIGHT 2 (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The Institute for Clinical and Economic Review stated fezolinetant's evidence is rated as promising but inconclusive to determine whether fezolinetant provides a net health benefit for patients over the long term; however, using point estimates from short-term clinical trials, analyses suggest this drug would achieve common thresholds for cost-effectiveness if priced between $2,000 . Am J Public Health. 2014;13:203-211. What is the technology utilized in the development of Fezolinetant (ESN364)? Przegl Menopauzalny [Menopause Rev]. 2014;21:924-932. The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155)and SKYLIGHT 2 (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. The recommended dose is 500 mg given once a month, with an additional 500-mg dose two weeks after the first dose. Further, it also consists of future market assessments inclusive of the market forecast, SWOT analysis, market competitors, and other emerging therapies. Menopause. 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. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.7,8,9 The safety and efficacy of fezolinetant are under investigation and have not been established. Women were enrolled at over 280 sites within the U.S.,CanadaandEurope. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. It is developed by Astellas Pharma which acquired it from Ogeda (formerly Euroscreen) in April 2017. However, Apellis might not have the market to itself for long as Iveric Bio's Zimura has a Pdufa date in August. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. By using this site, you accept our use of cookies as described in our privacy policy. 4th ed. What is the forecasted market scenario of Fezolinetant (ESN364)? 2 Jones RE, Lopez KH, eds. 7Depypere H, Timmerman D, Donders G, Sieprath P, Ramael S, Combalbert J, et al. For E.S.T Office Hours Call 1-917-300-0470 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 . Menopause. The new PDUFA date is set for May 22. 2Fraser GL, Lederman S, Waldbaum A, et al. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.3,4,7 The safety and efficacy of fezolinetant are under investigation and have not been established. Overview. Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 1 Depypere H, Timmerman D, Donders G, et al. About FezolinetantFezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. 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. Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1,2. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. For 100 years, the Endocrine Society has been at the forefront of hormone science and public health. 2005;3:47. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Viking accuses Chinese biotech of 'ruse' to raid trade secrets and make off with NASH cache. The impact of this matter on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. Proposed indication. Waltham, MA: Elsevier, 2014. The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. 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. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. If you would like to customise your choices, click 'Manage privacy settings'. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 7 Fraser GL, Hoveyda HR, Clarke IJ, et al. If approved by the FDA, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause, TOKYO, Aug. 18, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for fezolinetant, an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. C[C@@H]1C2=NN=C(N2CCN1C(=O)C3=CC=C(C=C3)F)C4=NC(=NS4)C, InChI=1S/C16H15FN6OS/c1-9-13-19-20-14(15-18-10(2)21-25-15)23(13)8-7-22(9)16(24)11-3-5-12(17)6-4-11/h3-6,9H,7-8H2,1-2H3/t9-/m1/s1, List of investigational sex-hormonal agents GnRH/gonadotropins, "Optimization of Novel Antagonists to the Neurokinin3 Receptor for the Treatment of Sex-Hormone Disorders (Part II)", "Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study", "A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause", "The NK3 Receptor Antagonist ESN364 Suppresses Sex Hormones in Men and Women", "The NK3 Receptor Antagonist ESN364 Interrupts Pulsatile LH Secretion and Moderates Levels of Ovarian Hormones Throughout the Menstrual Cycle", "Gone in a Flash: New Drug Class Targets Menopause Symptom", "Ogeda Announces Positive Data From Phase IIa Trial Of Fezolinetant In The Treatment Of Menopausal Hot Flashes", https://en.wikipedia.org/w/index.php?title=Fezolinetant&oldid=1147159156, Chemical pages without DrugBank identifier, Articles containing unverified chemical infoboxes, Creative Commons Attribution-ShareAlike License 3.0, This page was last edited on 29 March 2023, at 06:05. A detailed description of regulatory milestones, development activities, and some key findings provide the current development scenario of Fezolinetant (ESN364). Severity and frequency of moderate/severe VMSs were reduced from the first day of treatment. Sorry, you need to enable JavaScript to visit this website. US FDA approval tracker: February 2023. 2015;156:4214-25. Endocrinology. 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. The study treatments are fezolinetant 30 mg (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. Senior Communications Manager, Public Relations Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. When typing in this field, a list of search results will appear and be automatically updated as you type. The study was placebo-controlled for 12 weeks followed by a 40-week blinded extension to assess the maintenance of effect. A comprehensive product overview including the product description, mechanism of action, dosage and administration, Research and Development activity. Genevieve Neal-Perry, MD, PhD, discusses her research on fezolinetant as a treatment for hot flashes. "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Vasomotor symptoms in 7 Major Markets. Japan-based Astellas Pharma has filed a New Drug Application for fezolinetant, an investigational selective neurokinin 3 (NK3) receptor antagonist developed for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. J Clin Endocrinol Metab. SKYLIGHT 4 is a randomized, placebo-controlled, double-blind Phase III clinical trial in over 1,800 women investigating the long-term (52-week) safety of fezolinetant in women seeking treatment for relief of VMS associated with menopause. Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 1 Depypere H, Timmerman D, Donders G, et al. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant, Astellas Submits Fezolinetant New Drug Application to U.S. FDA. 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). For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. 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. This website is intended for U.S. residents only. Sorry, you need to enable JavaScript to visit this website. It is being developed by Astellas. The report contains forecasted sales for Fezolinetant (ESN364) till 2030. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science intoVALUE for patients. 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. Which company is developing Fezolinetant (ESN364) along with the phase of the clinical study? Fezolinetant ( INN ; ESN-364 ) -3 (NK 3 ) Ogeda ( Euroscreen) . It is developed by Astellas Pharma which acquired it from Ogeda (formerly Euroscreen) in April 2017. Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. Menopause. 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. Elinzanetant. "Based on our initial assessment, we are pleased with the outcome of the SKYLIGHT 4 study, which further characterizes the long-term safety of fezolinetant," said Nancy Martin, M.D., PharmD, Vice President, Global Medical Head, Medical Specialties, Astellas. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. Select one or more newsletters to continue. 2015;156:4214-4225. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Press Releases, Policy Letters and more For 100 years, the Endocrine Society has been at the forefront of hormone science and public health. Our communications team will respond to verified media requests within 24-48 hours as appropriate. . If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. 8Fraser GL, Lederman S, Waldbaum A, Kroll R, Santoro N, Lee M, et al. 3Fraser GL, Hoveyda HR, Clarke IJ, et al. The study's primary objectives were to evaluate the effect offezolinetanton endometrial health and the long-term safety and tolerability of fezolinetant. For media inquiries and reporter requests, please click here to fill out a request form. Fezolinetant - Ogeda Alternative Names: A2693; AS3472693-00; ESN-364 Latest Information Update: 15 Mar 2023. Available for Android and iOS devices. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. Pooled analyses will also be presented from SKYLIGHT 1 and SKYLIGHT 2 . For the co-primary endpoint of reduction in mean frequency of moderate to severe VMS versus placebo, fezolinetant 30 mg demonstrated a -1.82 (p=<0.001) and -1.86 (p=<0.001) mean change per day at . Stem-cell based therapy shows promise in treating high-risk type 1 diabetes, COVID-19 vaccination appears to be safe for patients treated for hypothyroidism, Phase 3 study finds fezolinetant reduces the frequency and severity of menopausal hot flashes, Accelerating Breakthroughs & Improving Care.
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