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. 2008;11:32-43. "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 . Select one or more newsletters to continue. Col 2, para 1, lines 4-6. Menopause. Ces symptmes ont un impact important sur le sommeil et la qualit de vie. : HY-19632 CAS No. 2006;96:1226-1235. The PDUFA target action date is Feb. 22, 2023, following use of a priority review voucher. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Endocrinology. Faslodex is available as a solution for injection in prefilled syringes (250 mg). 7Depypere H, Timmerman D, Donders G, Sieprath P, Ramael S, Combalbert J, et al. Menopause. [4][5], Fezolinetant shows high affinity for and potent inhibition of the NK3 receptor in vitro (Ki = 25nM, IC50 = 20nM). About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. SKYLIGHT 4 study results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg once daily. : 1629229-37-3 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses : Laboratory chemicals, manufacture of substances. For more information, please visit our website at https://www.astellas.com/en. The study's primary objectives were to evaluate the effect offezolinetanton endometrial health and the long-term safety and tolerability of fezolinetant. The topline data further characterize the long-term safety profile of fezolinetant and will inform future regulatory filings. For more information, please visit our website at https://www.astellas.com/en. Proposed indication. 2Jones RE, Lopez KH, eds. 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. 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. Faslodex can only be obtained with a prescription. 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. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. Fezolinetant reduced moderate/severe VMS by about 62% to 81% at week 4, depending on dose, compared with about a 39% reduction with placebo. 2015;156:4214-4225. 3Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. 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 site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. Health Qual Life Outcomes. 2015;156:4214-25. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. The study treatments were fezolinetant 30 milligrams (mg) (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of . A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. By using this site, you accept our use of cookies as described in our privacy policy. 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. California Declaration of Comprehensive Compliance Program, Vermonts Pharmaceutical Marketer Price Disclosure, Wholesale Acquisition Cost Information for Colorado Prescribers, Consumer Product Safety Commission Regulations, the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant", Understanding the Gastric and GEJ Cancer Landscape. For media inquiries and reporter requests, please click here to fill out a request form. Senior Communications Manager, Public Relations If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Which company is developing Fezolinetant (ESN364) along with the phase of the clinical study? 1 Utian WH. 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 nonhormonal selective neurokinin 3 (NK3) receptor antagonist. Director, Communications and Media Relations Fezolinetant (ESN364) Analytical Perspective, In-depth Fezolinetant (ESN364) Market Assessment. "We look forward to the FDA's review of our application, and the potential to offer a first-in-class nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause.". J ClinEndocrinol Metab. Climacteric. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. 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. 888-776-0942 from 8 AM - 10 PM ET. A comprehensive product overview including the product description, mechanism of action, dosage and administration, Research and Development activity. Phone: (202)-971-3611 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. It is being developed by Astellas. However, Apellis might not have the market to itself for long as Iveric Bio's Zimura has a Pdufa date in August. For the treatment of vasomotor symptoms associated with menopause. Elaborated details on regulatory milestones and other development activities have been provided in this report. . It is developed by Astellas Pharma which acquired it from Ogeda (formerly Euroscreen) in April 2017. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Menopause, a normal part of aging, is the time of a woman's last period. "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Vasomotor symptoms in 7 Major Markets. 4th ed. 2 Jones RE, Lopez KH, eds. 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. When typing in this field, a list of search results will appear and be automatically updated as you type. 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. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. [8][9] NK3 receptor antagonists are anticipated as a useful clinical alternative to estrogens for management of hot flashes, but with potentially reduced risks and side effects.[8][9]. 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 . A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. 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. The website you are about to visit is not owned or controlled by Astellas. Our communications team will respond to verified media requests within 24-48 hours as appropriate. Climacteric. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. 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. Published: Aug. 18, 2022 at 2:30 a.m. 2014;21:924-932. 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. Astellas Pharma Inc., submitted a marketing authorization application (MAA) for fezolinetant, an investigational oral, nonhormonal compound. Endocrinology. The report contains forecasted sales for Fezolinetant (ESN364) till 2030. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant. Astellas acquired fezolinetant for 500 million euros upfront in 2017. This website is intended for U.S. residents only. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Press Release. 3Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. 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. Just days before the approval decision date, the FDA has extended the review by three months to give it more time to complete its assessment. "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 . Symptoms of menopause include hot flashes and night sweats. Am J Public Health. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1,2. About the launch of fezolinetant, it will not be the linear . . The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. Women were enrolled at over 180 sites within the U.S.,CanadaandEurope. The product details cover mechanism of action, dosage and administration, route of synthesis, and Research and development activity including regulatory milestones, and other development activities. [8][9] This would seem to be independent of their actions on the hypothalamicpituitarygonadal axis and hence on sex hormone production. Endocrinology. Health Qual Life Outcomes. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. Fezolinetant (ESN364) is a Neurokinin 3 receptor antagonists under development for the treatment of Vasomotor symptoms. 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. Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. Application targets treatment of moderate to severe vasomotor symptoms associated (VMS) with menopause, 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). 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. A total of 302 women with moderate to . Adis is an information provider. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. 2014;13:203-211. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS due to menopause.1,2,3 The safety and efficacy of fezolinetant are under investigation and have not been established. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. For more information, please visit our website at https://www.astellas.com/en. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. 7 Fraser GL, Hoveyda HR, Clarke IJ, et al. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. 2Fraser GL, Lederman S, Waldbaum A, et al. Available for Android and iOS devices. Breakthroughs in women's health are uncommon; accordingly, it is exciting to read results from a phase 3 trial of fezolinetant (), a selective neurokinin-3 receptor (NK3R) antagonist, confirming its efficacy and safety in treating menopausal vasomotor symptoms (VMS).VMS affect up to 80% of women, approximately 25% bothersome enough to need treatment, persistent for a median of 7 years, with . If approved, fezolinetant would treat patients with moderate-to-severe hot flashes and/or night sweats associated with menopause. Menopause, a normal part of aging, is the time of a woman's last period. 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. What is the forecasted market scenario of 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. 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. Jan 3, 2023 06:30am. 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. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS due to menopause.1,2,3The safety and efficacy of fezolinetant are under investigation and have not been established. The safety and efficacy of fezolinetant are under investigation and have not been established. About Fezolinetant Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. For media inquiries and reporter requests, please click here to fill out a request form. Waltham, MA: Elsevier, 2014. Menopause. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. About VMS Associated with Menopause VMS, characterized by hot flashes (also called hot flushes) and/or night sweats are common symptoms of menopause.1,2 Worldwide, more than half of women 40 to 64 years of age experience VMS and, in the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition.3,4,5,6VMS can have a disruptive impact on women's daily activities and overall quality of life.1, About FezolinetantFezolinetant is an investigational, oral nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause.
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