Padcev (enfortumab vedotin) for the Treatment of Urothelial Cancer Fezolinetant (ESN364) is a proprietary, oral, small-molecule, discovered and developed by Ogeda for the purpose of the treatment of women's health disorders. [4][5], Fezolinetant shows high affinity for and potent inhibition of the NK3 receptor in vitro (Ki = 25nM, IC50 = 20nM). Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. 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. . 4Gold EB, Colvin A, Avis N, et al. ", "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. Language links are at the top of the page across from the title. Human Reproductive Biology. Menopause. News | Astellas Pharma Inc. 2014;13:203-211. 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. 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 . 2014;21:924-932. Contacts Jean Combalbert: Ruth Devenyns: Chief Executive Officer: Chief Financial Officer +32 71 348 520 +32 71 348 500: info@ogeda.com : info@ogeda.com : Consilium Strategic Communications Endocrinology. 2019;104:5893-5905. Which are the late-stage emerging therapies under development for the treatment of Vasomotor symptoms. Joanne Fagg. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. Am J Public Health. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. [7] However, the inhibition of sex hormone production by NK3 receptor inactivation tends to be less complete and "non-castrating" relative to that of GnRH modulators, and so they may have a reduced incidence of menopausal-like side effects such as loss of bone mineral density. Women were enrolled at over 280 sites within the U.S.,CanadaandEurope. Before Seagen's $43 billion deal to be acquired by Pfizer last month, the biotech company had received takeover offers going back to at least 2019, according to a new filing that provides a play . The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. The PDUFA target action date is Feb. 22, 2023, following use of a priority review voucher. 7Depypere H, Timmerman D, Donders G, Sieprath P, Ramael S, Combalbert J, et al. 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). 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. 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. 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. 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. It is developed by Astellas Pharma which acquired it from Ogeda (formerly Euroscreen) in April 2017. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. 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. Fezolinetant (ESN364): Astellas' Neurokinin 3 Receptor Antagonists VMS is characterized by hot flushes and/or night sweats which are . Elinzanetant - Wikipedia Climacteric. The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). 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) Clinical Assessment. For E.S.T Office Hours Call 1-917-300-0470 Climacteric. 2008;11:32-43. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Vasomotor symptoms in 7 Major Markets. Climacteric. Astellas gets safety win for phase 3 menopause drug, setting up US, EU The report also highlights the drug research and development activity details across the United States, Europe and Japan. 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. At the 45 mg dose, fezolinetant showed a -2.55 (p=<0.001) and -2.53 (p=<0.001) mean change per day in VMS frequency versus placebo at weeks 4 and 12, respectively. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. The study is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. Neurokinin Receptor Antagonist, Fezolinetant, for Treatment of Price : $50 * Buy Profile. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. Read about our historyand how we continue to serve the endocrine community. Randomisation was double-blind and the randomisation number was assigned based on information obtained from Interactive Response Fezolinetant - Wikipedia Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science intoVALUE for patients. Study on Fezolinetant shows encouraging results on women with VMS 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. Fezolinetant (ESN364) is a proprietary, oral, small-molecule, discovered and developed by Ogeda for the purpose of the treatment of women's health disorders. . For more information, please visit our website at https://www.astellas.com/en. About FezolinetantFezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. 2 Jones RE, Lopez KH, eds. 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. BREAKING: Fezolinetant news - Hotflash Inc 2006;96:1226-35. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. [8][9] This would seem to be independent of their actions on the hypothalamicpituitarygonadal axis and hence on sex hormone production. ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com 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 . 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. Phase 3 study finds fezolinetant reduces the frequency and severity of menopausal hot flashes. Menopause. Fezolinetant reduced moderate/severe VMS by about 62% to 81% at week 4, depending on dose, compared with about a 39% reduction with placebo. 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. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant 2014;21:924-932. 4th ed. Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. [emailprotected]. Elaborated details on regulatory milestones and other development activities have been provided in this report. The website you are about to visit is not owned or controlled by Astellas. 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. . Les symptmes vasomoteurs de la mnopause (SVM), en premier lieu les bouffes de chaleur, touchent une large proportion des femmes (> 80 %) lors de la primnopause, et dix ans plus tard 30 % 50 % en souffrent toujours. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms Waltham, MA: Elsevier, 2014. Fezolinetant is an investigational selective neurokinin 3 (NK3) receptor antagonist. 2015;156:4214-4225. 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. Fezolinetant is an investigational oral . After rolling up nothing but positive PhIII data for the FDA and EMA 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 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. 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. 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. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2. This website is intended for U.S. residents only. For more information, please visit our website at https://www.astellas.com/en. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. "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 . 2006;96:1226-1235. The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. Le fezolinetant, un nouveau traitement non hormonal des bouffes de Hot flashes can interrupt a woman's daily life. The new PDUFA date is set for May 22. By using this site, you accept our use of cookies as described in our privacy policy. About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 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. For more information, please visit our website at https://www.astellas.com/en. Fezolinetant (ESN364) is a Neurokinin 3 receptor antagonists under development for the treatment of Vasomotor symptoms. The present invention relates to deuterated fezolinetant ( R )-(4-fluorophenyl)-(8-methyl-3-(3-(methyl- d3 )-1,2,4-thiadiazol-5-yl)-5,6-dihydro-[1,2,4]trizolo[4,3-a]pyrazin-7(8H)-yl)methanone, or a pharmaceutically acceptable solvate thereof, as NK-3 antagonist. Thesafety and efficacy of fezolinetant are under investigation and have not been established. FDA to Review NDA for Nonhormonal Therapy for Menopause About the launch of fezolinetant, it will not be the linear . Our communications team will respond to verified media requests within 24-48 hours as appropriate. 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. Genevieve Neal-Perry, MD, PhD, discusses her research on fezolinetant as a treatment for hot flashes. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant 2 Fraser GL, Lederman S, Waldbaum A, et al. The safety and efficacy of fezolinetant are under investigation and have not been established. Astellas Provides Update on Fezolinetant New Drug Application in U.S. For further information: Contacts for inquiries or additional information: Astellas Portfolio Communications, Anna Criddle, +1 (847) 682-4812, anna.criddle@astellas.com, Astellas Pharma Inc. Corporate Advocacy & Relations, +81-3-3244-3201. 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 . For more information about this report visit https://www.researchandmarkets.com/r/q7m5ni, ResearchAndMarkets.com Product name : Fezolinetant Catalog No. 1 Depypere H, Timmerman D, Donders G, et al. 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. 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. Am J Public Health. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. Feb 19, 2021. It is being developed by Astellas. OR06-5 Fezolinetant for Treatment of Moderate-to-severe Vasomotor 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. If approved by regulatory authorities, fezolinetant would be a first-in-class, nonhormonal treatment option to reduce the frequency and severity of 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. Faslodex is available as a solution for injection in prefilled syringes (250 mg). Symptoms of menopause include hot flashes and night sweats. :20220818fezolinetant-VMS . Menopause. Adis is an information provider. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. 2005;3:47. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. 4th ed. Published: Aug. 18, 2022 at 2:30 a.m. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. 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. 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. 2008;11:32-43. 2014;13:203-11. Improvements were achieved in all quality-of-life . 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. 6Williams RE, Kalilani L, DiBenedetti DB, et al. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause. Image. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded and placebo-controlled study designed to investigate long-term safety of fezolinetant. 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. 2020;27:382-92. FDA Updates for the Week of Aug. 15, 2022 Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. If you would like to customise your choices, click 'Manage privacy settings'. It is estimated that 60% to 80% of . Women were enrolled at over 180 sites within the U.S.,CanadaandEurope. Phone: (202)-971-3655 Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science intoVALUE for patients. 2015;156:4214-25. 9Fraser GL, Hoveyda HR, Clarke IJ, Ramaswamy S, Plant TM, Rose C, et al. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant, For further information: Astellas Portfolio Communications: Anna Otten, +1 (847) 682-4812, anna.otten@astellas.com; Astellas Pharma Inc. Corporate Advocacy & Relations: +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. Severity and frequency of moderate/severe VMSs were reduced from the first day of treatment. Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030 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. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant"issued on August 18, 2022. News | Astellas Pharma Inc. 2020;27:382-392. EP3428168A1 - Deuterated fezolinetant - Google Patents 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 . 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. Health Qual Life Outcomes. 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. Cision Distribution 888-776-0942 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. 3Fraser GL, Hoveyda HR, Clarke IJ, et al. Astellas Provides Update on Fezolinetant New Drug Application in U.S. Our communications team will respond to verified media requests within 24-48 hours as appropriate. Col 2, para 1, lines 4-6. [1] [2] 2017 5 I . The topline data further characterize the long-term safety profile of fezolinetant and will inform future regulatory filings. . Astellas Announces Topline 12-week Results from Phase 3 Study of 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. Application type. Waltham, MA: Elsevier, 2014:120. "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. For media inquiries and reporter requests, please click here to fill out a request form. 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. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor . The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. 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. Astellas Pharma Inc. (ALPMF) Q4 2022 Earnings Call Transcript 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.
