"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. 8Fraser GL, Lederman S, Waldbaum A, Kroll R, Santoro N, Lee M, et al. The trial is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Contacts. The SKYLIGHT 4 findings, along with the results from two pivotal Phase 3 clinical trials, SKYLIGHT 1 and SKYLIGHT 2, will provide the foundational data for regulatory submissions in the U.S. and Europe. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded and placebo-controlled study designed to investigate long-term safety of fezolinetant. The analysis comprised 484 women (fezolinetant 30mg n=166, fezolinetant 45mg n=167, placebo/fezolinetant 30mg n=76, placebo/fezolinetant 45mg n=75). 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. Read about our historyand how we continue to serve the endocrine community. 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. Fezolinetant (ESN364) is a proprietary, oral, small-molecule, discovered and developed by Ogeda for the purpose of the treatment of women's health disorders. It is being developed by Astellas. . By using this site, you accept our use of cookies as described in our privacy policy. [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. This study was for women in menopause with moderate to severe hot flashes. 2014;13:203-11. 2015;156:4214-4225. 1 Depypere H, Timmerman D, Donders G, et al. The safety and efficacy of fezolinetant are under investigation and have not been established. The report also features the SWOT analysis with analyst insights and key findings of Fezolinetant (ESN364). 3Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. It is being developed by Astellas. 2014;13:203-211. The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). The safety and efficacy of fezolinetant are under investigation and have not been established. 4th ed. 3Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. 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. About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. Fezolinetant ( INN ; ESN-364 ) -3 (NK 3 ) Ogeda ( Euroscreen) . 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. The PDUFA target action date is Feb. 22, 2023, following use of a priority review voucher. 2 Jones RE, Lopez KH, eds. A detailed description of regulatory milestones, development activities, and some key findings provide the current development scenario of Fezolinetant (ESN364). 2020;27:382-392. The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. The trials are double-blinded and placebo-controlled for the first 12 weeks followed by 40-week active treatment extension period. [1] [2] 2017 5 I . For media inquiries and reporter requests, please click here to fill out a request form. Women were enrolled at over 180 sites within the U.S.,CanadaandEurope. For more information, please visit our website at https://www.astellas.com/en. Phil Taylor. 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. For GMT Office Hours Call +353-1-416-8900, Internet Explorer presents a security risk. About FezolinetantFezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Aug 18 . This website is intended for U.S. residents only. For more information about this report visit https://www.researchandmarkets.com/r/q7m5ni, ResearchAndMarkets.com 5Freeman EW, Sammel MD, Sanders RJ. "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.". Improvements were achieved in all quality-of-life . For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant"issued on August 18, 2022. The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. 6Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Granger AL, Fehnel SE, et al. 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 . 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. The new PDUFA date is set for May 22. About the launch of fezolinetant, it will not be the linear . SKYLIGHT 4 study results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg once daily. 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. [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]. 1 Depypere H, Timmerman D, Donders G, et al. "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 SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. 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. 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 Hot flashes can interrupt a woman's daily life. Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the . 2014;21:924-932. Sorry, you need to enable JavaScript to visit this website. A treatment for moderate to severe vasomotor symptoms (VMS) has been accepted by the European Medicines Agency (EMA) for regulatory review. The therapies under development are focused on novel approaches to treat/improve the disease condition. 2019;104:5893-5905. [6] As such, they are similar to GnRH modulators, and present as a potential clinical alternative to them for use in the same kinds of indications. Menopause. 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. 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. Data support the clinical use of fezolinetant as a non-hormonal treatment for vasomotor symptoms associated with menopause. The MarketWatch News Department was not involved in the creation of this content. "I am excited by the potential of a new nonhormonal treatment option for women experiencing moderate to severe VMS associated with menopause.". About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. "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.". 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. Which company is developing Fezolinetant (ESN364) along with the phase of the clinical study? Menopause, a normal part of aging, is the time of a woman's last period. Health Qual Life Outcomes. Phone: (202)-971-3611 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. Accepted date. 2006;96:1226-1235. Menopause. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. Przegl Menopauzalny [Menopause Rev]. A total of 302 women with moderate to . Col 2, para 1, lines 4-6. The website you are about to visit is not owned or controlled by Astellas. The topline data further characterize the long-term safety profile of fezolinetant and will inform future regulatory filings. Press Release. Endocrinology. The study is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. 2019;104:5893-5905. 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. Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 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. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. 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 4clinical 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 (VMS) which will support future regulatory filing submissions. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Menopause. 1Utian WH. Fezolinetant (ESN364) is a proprietary, oral, small-molecule, discovered and developed by Ogeda for the purpose of the treatment of women's health disorders. 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. 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. The report also covers the patents information with expiry timeline around Fezolinetant (ESN364). Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Feb 19, 2021. The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. About Fezolinetant 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. The study was placebo-controlled for 12 weeks followed by a 40-week blinded extension to assess the maintenance of effect. Fezolinetant (ESN364) is a Neurokinin 3 receptor antagonists under development for the treatment of Vasomotor symptoms. 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. 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. 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. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. 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. today announced a New Drug Application (NDA) for fezolinetant has been submitted to the U.S. Food and Drug . The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. 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. Sorry, you need to enable JavaScript to visit this website. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. Waltham, MA: Elsevier, 2014. Overview. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant", Astellas Enters into Definitive Agreement to Acquire Iveric Bio, Results from Astellas' Phase 3 SPOTLIGHT Trial of Investigational Zolbetuximab Published in The Lancet. "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Vasomotor symptoms in 7 Major Markets. M.D., senior vice president and head of development therapeutic areas at Astellas, said in a press release. "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 . 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. Hot flashes can interrupt a woman's daily life. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. Within the NDA, Astellas proposes a 45 mg daily dose, which is subject to the FDA's review. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant"issued on August 18, 2022. 4Gold EB, Colvin A, Avis N, Bromberger J, Greendale GA, Powell L, et al. For media inquiries and reporter requests, please click here to fill out a request form. Fezolinetant (ESN364) Analytical Perspective, In-depth Fezolinetant (ESN364) Market Assessment. 2008;11:32-43. Further . For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause. Genevieve Neal-Perry, MD, PhD, discusses her research on fezolinetant as a treatment for hot flashes. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Proposed indication. For more information, please visit our website at https://www.astellas.com/en. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. SKYLIGHT 4 is a randomized, placebo-controlled, double-blind Phase 3 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. 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. Am J Public Health. The impact of this matter on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. US FDA approval tracker: February 2023. 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. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Prior art date 2017-07-12 Legal status (The legal status is an assumption and . 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. 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 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. 2Fraser GL, Lederman S, Waldbaum A, et al. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. 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. Menopause. 2015;156:4214-4225. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. It is estimated that 60% to 80% of . 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. "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. Women were enrolled at over 180 sites within the U.S.,CanadaandEurope. For more information, please visit our website at https://www.astellas.com/en. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. 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. 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. With the trio of trials now complete, Astellas says it can press ahead with regulatory filings for the new drug, keeping its nose ahead of its main rival Bayer, which paid $425 million upfront to . Astellas are not responsible for the information or services on this site. Treatment for: Menopausal Disorders, Hot Flashes. 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 . The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155)and SKYLIGHT 2 (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. 2014;21:924-932. Cision Distribution 888-776-0942 SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. [6][7], Unlike GnRH modulators, but similarly to estrogens, NK3 receptor antagonists including fezolinetant and MLE-4901 (also known as AZD-4901, formerly AZD-2624) have been found to alleviate hot flashes in menopausal women. 7 Fraser GL, Hoveyda HR, Clarke IJ, et al. 2005;3:47. 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). The NDA is supported by results from the BRIGHT SKY program, which included three Phase 3 clinical trials that collectively enrolled over 2,800 women with VMS across the U.S., Canada and Europe. 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. Menopause. By using this site, you accept our use of cookies as described in our privacy policy. Comprehensive coverage of the late-stage emerging therapies (Phase III) for Vasomotor symptoms. Astellas are not responsible for the information or services on this site. Severity and frequency of moderate/severe VMSs were reduced from the first day of treatment. If approved, fezolinetant would treat patients with moderate-to-severe hot flashes and/or night sweats associated with menopause. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. 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. 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. Human Reproductive Biology. 1.3 Details of the supplier of the safety data sheet Company: MedChemExpress USA Tel: 609-228-6898 Fax: 609-228-5909 J ClinEndocrinol Metab. All rights reserved. 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 fezolinetant," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. 6Williams RE, Kalilani L, DiBenedetti DB, et al. Climacteric. 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 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. Jan 3, 2023 06:30am. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. 2005;3:47.

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