Our communications team will respond to verified media requests within 24-48 hours as appropriate. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms :20220818fezolinetant-VMS . 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 . 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. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist. Follow us on Twitter at@TheEndoSocietyand@EndoMedia. 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. 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). Am J Public Health. Ces symptmes ont un impact important sur le sommeil et la qualit de vie. The safety and efficacy of fezolinetant are under investigation and have not been established. : 1629229-37-3 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses : Laboratory chemicals, manufacture of substances. The website you are about to visit is not owned or controlled by Astellas. Viking accuses Chinese biotech of 'ruse' to raid trade secrets and make off with NASH cache. Help us improve the Therapeutic Goods Administration site. Active ingredients. Vasomotor SymptomsVMSfezolinetant . 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. About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 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. 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. For media inquiries and reporter requests, please click here to fill out a request form. Thesafety and efficacy of fezolinetant are under investigation and have not been established. Within the NDA, Astellas proposes a 45 mg daily dose, which is subject to the FDA's review. 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.. Astellas' bid to bring menopause drug candidate fezolinetant to market has hit a last-minute snag. 2 Fraser GL, Lederman S, Waldbaum A, et al. 4Gold EB, Colvin A, Avis N, Bromberger J, Greendale GA, Powell L, et al. 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. 5Freeman EW, Sammel MD, Sanders RJ. Waltham, MA: Elsevier, 2014. 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. Padcev (enfortumab vedotin) for the Treatment of Urothelial Cancer 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. Astellas gets safety win for phase 3 menopause drug, setting up US, EU Jan 3, 2023 06:30am. The report also covers the patents information with expiry timeline around Fezolinetant (ESN364). The safety and efficacy of fezolinetant are under investigation and have not been established. 2020;27:382-92. Additionally, for the co-primary endpoint of reduction in mean severity of moderate to severe VMS versus placebo, fezolinetant 30 mg demonstrated a -0.15 (p=<0.021) and -0.16 (p=0.049) mean change per day at weeks 4 and 12 . Endocrinology. Hot flashes can interrupt a woman's daily life. Improvements were achieved in all quality-of-life . There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. Fezolinetant Reduces Vasomotor Symptoms in Menopause J Clin Endocrinol Metab. Director, Communications and Media Relations 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. Waltham, MA: Elsevier, 2014:120. For more information about this report visit https://www.researchandmarkets.com/r/q7m5ni, ResearchAndMarkets.com J ClinEndocrinol Metab. 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. [emailprotected], Jenni Glenn Gingery Fezolinetant reduced moderate/severe VMS by about 62% to 81% at week 4, depending on dose, compared with about a 39% reduction with placebo. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Vasomotor symptoms in 7 Major Markets. Fezolinetant (ESN364) is a proprietary, oral, small-molecule, discovered and developed by Ogeda for the purpose of the treatment of women's health disorders. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Data support the clinical use of fezolinetant as a non-hormonal treatment for vasomotor symptoms associated with menopause. Press Releases, Policy Letters and more For 100 years, the Endocrine Society has been at the forefront of hormone science and public health. Endocrinology. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. 2 Jones RE, Lopez KH, eds. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the . Human Reproductive Biology. Fezolinetant | C16H15FN6OS - PubChem The drug is indicated for locally advanced or metastatic urothelial cancer patients who have previously been treated with platinum-containing chemotherapy or programmed cell death ligand 1 (PD-1) or PD-L1 . Endocrinology. 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. 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's primary objectives were to evaluate the effect offezolinetanton endometrial health and the long-term safety and tolerability of fezolinetant. [4][5], Fezolinetant shows high affinity for and potent inhibition of the NK3 receptor in vitro (Ki = 25nM, IC50 = 20nM). Waltham, MA: Elsevier, 2014. 2Jones RE, Lopez KH, eds. Fezolinetant is an investigational oral . 2Fraser GL, Lederman S, Waldbaum A, et al. 2014;13:203-11. Laura Wood, Senior Press Manager The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. 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. Health Qual Life Outcomes. 9Fraser GL, Hoveyda HR, Clarke IJ, Ramaswamy S, Plant TM, Rose C, et al. February 2023 decisions expected from the FDA 2019;104:5893-5905. Menopause, a normal part of aging, is the time of a woman's last period. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 2008;11:32-43. 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. For media inquiries and reporter requests, please click here to fill out a request form. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Regarding AT132, we submitted a series of responses to clinical hold by FDA by -- in March. 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. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial.
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