2005;3:47. Contacts. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. Product name : Fezolinetant Catalog No. :20220818fezolinetant-VMS . : 1629229-37-3 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses : Laboratory chemicals, manufacture of substances. 2Fraser GL, Lederman S, Waldbaum A, et al. A comprehensive product overview including the product description, mechanism of action, dosage and administration, Research and Development activity. ", "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. It is being developed by Astellas. 4Gold EB, Colvin A, Avis N, Bromberger J, Greendale GA, Powell L, et al. 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 . Thesafety and efficacy of fezolinetant are under investigation and have not been established. Time Frame: From first dose date up to 21 days after last dose (up to 55 weeks) 2015;156:4214-25. 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. . 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. [8][9] This would seem to be independent of their actions on the hypothalamicpituitarygonadal axis and hence on sex hormone production. "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.". The report also covers the patents information with expiry timeline around Fezolinetant (ESN364). The PDUFA target action date is Feb. 22, 2023, following use of a priority review voucher. The impact of this matter on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. Astellas Pharma Inc., submitted a marketing authorization application (MAA) for fezolinetant, an investigational oral, nonhormonal compound. 1 Depypere H, Timmerman D, Donders G, et al. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. Fezolinetant is an investigational selective neurokinin 3 (NK3) receptor antagonist. In 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. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. 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. The recommended dose is 500 mg given once a month, with an additional 500-mg dose two weeks after the first dose. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. 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. 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. In 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. Press Release. 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 more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. Treatment for: Menopausal Disorders, Hot Flashes. Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the . Endocrinology. 2006;96:1226-1235. Comprehensive coverage of the late-stage emerging therapies (Phase III) for Vasomotor symptoms. Fezolinetant (ESN364) is a Neurokinin 3 receptor antagonists under development for the treatment of Vasomotor symptoms. The website you are about to visit is not owned or controlled by Astellas. 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 analysis comprised 484 women (fezolinetant 30mg n=166, fezolinetant 45mg n=167, placebo/fezolinetant 30mg n=76, placebo/fezolinetant 45mg n=75). Ces symptmes ont un impact important sur le sommeil et la qualit de vie. Atlanta, GA June 11, 2022. 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. Women were enrolled at over 180 sites within the U.S.,CanadaandEurope. Sorry, you need to enable JavaScript to visit this website. Fezolinetant (ESN364) is a Neurokinin 3 receptor antagonists under development for the treatment of Vasomotor symptoms. About BRIGHT SKY Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155) and SKYLIGHT 2 (NCT04003142), enrolled over 1,020 women with moderate to severe VMS. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. What is the technology utilized in the development of Fezolinetant (ESN364)? For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. 7Depypere H, Timmerman D, Donders G, Sieprath P, Ramael S, Combalbert J, et al. Overview. 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 . Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. from 8 AM - 9 PM ET. For more information, please visit our website at https://www.astellas.com/en. 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. 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. The impact of this matter on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. 7Depypere H, Timmerman D, Donders G, Sieprath P, Ramael S, Combalbert J, et al. Severity and frequency of moderate/severe VMSs were reduced from the first day of treatment. Help us improve the Therapeutic Goods Administration site. "The fezolinetant NDA submission to the U.S. FDA is an important step in our efforts to bring to patients a first-in-class, nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause.". VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause. This website is intended for U.S. residents only. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. The website you are about to visit is not owned or controlled by Astellas. 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. If you would like to customise your choices, click 'Manage privacy settings'. The website you are about to visit is not owned or controlled by Astellas. 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. Menopause. 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. [1] [2][3], As of May 2017, it has completed phase I and phase IIa clinical trials for hot flashes in postmenopausal women. Astellas Announces Topline Results from Long-Term Phase 3 Safety Study of Fezolinetant which Inform Future Regulatory Filings for the Treatment of Vasomotor Symptoms Associated with Menopause, For further information: Contacts for inquiries or additional information: Astellas Portfolio Communications: Anna Otten, TEL: +1 (847) 682-4812, anna.otten@astellas.com; Astellas Pharma Inc., Corporate Advocacy & Relations, TEL: +81-3-3244-3201, California Declaration of Comprehensive Compliance Program, Vermonts Pharmaceutical Marketer Price Disclosure, Wholesale Acquisition Cost Information for Colorado Prescribers, Consumer Product Safety Commission Regulations, Understanding the Gastric and GEJ Cancer Landscape. Endocrine Society is a global community of physicians and scientists dedicated to accelerating scientific breakthroughs and improving patient health and well being. 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. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant, Astellas Submits Fezolinetant New Drug Application to U.S. FDA. For more information about this report visit https://www.researchandmarkets.com/r/q7m5ni, ResearchAndMarkets.com 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.. About FezolinetantFezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. 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). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Director, Communications and Media Relations Przegl Menopauzalny [Menopause Rev]. 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 . Published: Aug. 18, 2022 at 2:30 a.m. 8Fraser GL, Lederman S, Waldbaum A, Kroll R, Santoro N, Lee M, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. 3Fraser GL, Hoveyda HR, Clarke IJ, et al. 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). There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. 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. 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. J ClinEndocrinol Metab. Application type. This report provides a detailed market assessment of Fezolinetant (ESN364) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist. Faslodex is available as a solution for injection in prefilled syringes (250 mg). Waltham, MA: Elsevier, 2014. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. Fezolinetant (ESN364) is a proprietary, oral, small-molecule, discovered and developed by Ogeda for the purpose of the treatment of women's health disorders. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. 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. 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. 2019;104:5893-5905. Sorry, you need to enable JavaScript to visit this website. 1Utian WH. J Clin Endocrinol Metab. 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. Endocrinology. 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. The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). Senior Communications Manager, Public Relations Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 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. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Our communications team will respond to verified media requests within 24-48 hours as appropriate. Fezolinetant (ESN364) Clinical Assessment. What is the forecasted sales of Fezolinetant (ESN364) in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan? 2 Jones RE, Lopez KH, eds. 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. Colleen Williams Am J Public Health. A detailed picture of the Fezolinetant (ESN364) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2020-2030 is provided in this report along with a detailed description of the product. [emailprotected], Jenni Glenn Gingery What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Fezolinetant (ESN364) development? 9Fraser GL, Hoveyda HR, Clarke IJ, Ramaswamy S, Plant TM, Rose C, et al. 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. Select one or more newsletters to continue. 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. 2014;13:203-11. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. For GMT Office Hours Call +353-1-416-8900, Internet Explorer presents a security risk. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Cision Distribution 888-776-0942 J ClinEndocrinol Metab. 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). 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. Menopause. Image. 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. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. Climacteric. A (new medicine) Publication date. Within the NDA, Astellas proposes a 45 mg daily dose, which is subject to the FDA's review. 3Fraser GL, Hoveyda HR, Clarke IJ, et al. Fezolinetant is an investigational oral . 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. All rights reserved. For U.S./CAN Toll Free Call 1-800-526-8630 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 study being presented Saturday at ENDO 2022, the Endocrine Societys annual meeting in Atlanta, Ga. Senior Communications Manager, Public Relations, Director, Communications and Media Relations. 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 . 2019;104:5893-5905. For the treatment of vasomotor symptoms associated with menopause. 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 . Phone: (202)-971-3611 Hot flashes can interrupt a woman's daily life. 2020;27:382-392. About the launch of fezolinetant, it will not be the linear . 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. Climacteric. 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. 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. 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. Improvements were achieved in all quality-of-life . Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science intoVALUE for patients. 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. For media inquiries and reporter requests, please click here to fill out a request form. 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. 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 reduced moderate/severe VMS by about 62% to 81% at week 4, depending on dose, compared with about a 39% reduction with placebo. Send a Release; ALL CONTACT INFO; Contact Us. 2Jones RE, Lopez KH, eds. The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155)and SKYLIGHT 2 (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. 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. 2019;104:5893-905. Fezolinetant is an oral, nonhormonal therapy that works by blocking neurokinin B (NKB) binding on the KNDy neuron to moderate neuronal activity in the hypothalamus to reduce the frequency and severity of symptoms associated with menopause. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. For more information, please visit our website at https://www.astellas.com/en. 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. Menopause. fezolinetant. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. Elaborated details on regulatory milestones and other development activities have been provided in this report. For more information, please visit our website at https://www.astellas.com/en. 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 . Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. 6Williams RE, Kalilani L, DiBenedetti DB, et al. . Menopause, a normal part of aging, is the time of a woman's last period. The report provides the clinical trials information of Fezolinetant (ESN364) covering trial interventions, trial conditions, trial status, start and completion dates. Fezolinetant - Ogeda Alternative Names: A2693; AS3472693-00; ESN-364 Latest Information Update: 15 Mar 2023. Am J Public Health. 5Freeman EW, Sammel MD, Sanders RJ. The Endocrine Society is the worlds oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. 2020;27:382-392. Pooled analyses will also be presented from SKYLIGHT 1 and SKYLIGHT 2 . 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 fezolinetant) once a day or placebo (2 tablets) once a day. 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. Fezolinetant (INN; former developmental code name ESN-364) is a small-molecule, orally active, selective neurokinin-3 (NK3) receptor antagonist which is under development by for the treatment of sex hormone-related disorders. "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 . 2015;156:4214-25. Women who received fezolinetant 30 mg had a reduction in mean frequency of daily moderate to severe vasomotor events from 10.7 events per 24 hours at baseline to 5.4 events per 24 hours at week 4 and 4.5 events per 24 hours at week 12 (mean percentage change from baseline, -48% at week 4 and -56% at week 12).. Women who received fezolinetant 45 mg had a reduction in mean frequency of daily . 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. 4th ed. 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. to a previous release, Astellas was expecting to news about fezolinetant on February 22, a goal date that has now been extended by three months to May 22. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. 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.
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