If approved by the European Commission, fesolinetant will be a non-hormonal therapy for moderate to severe vasomotor symptoms associated with menopause.

Tokyo, September 29, 2022 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas Pharma Inc.” today announced that the European Medicines Agency (EMA) has submitted a marketing authorization application for fesolinetant, an investigational oral non-hormonal compound that is seeking approval for the treatment of patients with moderate to severe disease. (MAA) has been accepted for regulatory review. Vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and night sweats, is a common symptom of menopause.1,2

Erthan Arozler, MD, MPH, senior vice president and head of developmental therapeutics at Astellas Pharma, said: “With her EMA approval of our MAA for fesolinetant, we are one step closer to advancing the potential of a first-in-class non-hormonal treatment option for women worldwide. Europe Those experiencing menopause-related VMS are similar to the FDA accepting an NDA for women in the United States. ”

MAA is supported by the results of the BRIGHT SKY™ program. The program includes her three Phase 3 clinical trials, which collectively enrolled more than 2,800 women with VMS. EuropeUSA and CanadaResults from the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials characterize the efficacy and safety of fezolinetant in the treatment of moderate to severe VMS associated with menopause. Data from the SKYLIGHT 4™ safety study further characterize the long-term safety profile of fezolinetant. Within the MAA, Astellas has proposed a dose of 45 mg per day, which is subject to EMA review.

Fezolinetant is an investigational, non-hormone-selective neurokinin 3 (NK3) receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established.

This approval will have no impact on Astellas’ earnings forecast for the current fiscal year. March 31, 2023.

About the BRIGHT SKY™ Phase 3 Program

The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 women with moderate-to-severe VMS. The trial was double-blind, with her first 12 weeks placebo-controlled, followed by a 40-week treatment extension period. A woman was enrolled in her more than 180 sites within the United States, Canada, and Europe. SKYLIGHT 4™ (NCT04003389) is her 52-week, double-blind, placebo-controlled trial designed to investigate the long-term safety of fezolinetant. At SKYLIGHT 4, her over 1,800 women with VMS were enrolled at her over 180 sites within the United States, Canada, and Europe.

About VMS associated with menopause

VMS, characterized by hot flashes (also called hot flashes) and/or night sweats, are common symptoms of menopause.1,2 Globally, more than half of women aged 40-64 have had VMS, and it costs Europe It ranges from 56% to 97%.3,4,5 The prevalence of moderate to severe VMS in postmenopausal women is Europe reported as 40%.6 VMS can have a devastating impact on a woman’s daily activities and overall quality of life.1

About Fezolinetant

Fezolinetant is an oral, non-hormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant blocks neurokinin B (NKB) binding on kisspeptin/neurokinin/dynorphin (KNDy) neurons, attenuating neuronal activity in the thermoregulatory center of the brain (hypothalamus), leading to moderate to Reduces the frequency and severity of severe VMS. .7,8,9 The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee that agents will receive regulatory approval or be marketed for use under investigation.

About Astellas

Astellas Pharma Inc. is a pharmaceutical company that operates in more than 70 countries around the world. Focusing on biology and modality, we are promoting a Focus Area approach to find opportunities for continuous new drug discovery for diseases with high unmet medical needs. Additionally, we are looking beyond the basic Rx focus to create Rx+.® Healthcare solutions that combine our expertise and knowledge with cutting-edge technologies from external partners in various fields. Through these initiatives, Astellas will be at the forefront of medical change, transforming scientific innovation into value for patients. For more information, please visit our website https://www.astellas.com/en.


Statements in this press release regarding current plans, estimates, strategies, beliefs and other statements that are not historical facts are forward-looking statements regarding Astellas’ future performance. These statements are based on management’s current assumptions and beliefs in light of currently available information and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those set forth in the forward-looking statements. Such factors include, but are not limited to: (i) general economic conditions and changes in laws and regulations relating to the pharmaceutical market; (ii) exchange rate fluctuations; (iv) Astellas’ inability to effectively market existing and new products; (v) Astellas’ continued effective research and development of products that will be accepted by customers in a highly competitive market; and (vi) infringement of Astellas’ intellectual property rights by third parties. Information regarding pharmaceutical products (including those under development) contained in this press release is not intended as advertising or medical advice.


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2 Jones RE, Lopez KH, eds. human reproductive biology. Fourth Hen. Waltham, Massachusetts: Elsevier, 2014:120.

3 Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of menopausal symptoms – an intercontinental review. Przegl Menopauzalny [Menopause Rev]2014;13:203-211.

Four Gold EB, Corvin A, Avis N, et al. A Longitudinal Analysis of the Association Between Vasomotor Symptoms and Race/Ethnicity During the Menopausal Transition: A National Women’s Health Study. Am J Public Health2006;96:1226-1235.

Five Williams RE, Carilani L, DiBenedetti DB, et al. Frequency and severity of vasomotor symptoms in perimenopausal women usa. menopause2008; 11:32-43.

6 Nappi RE, Kroll R, Siddiqui E, et al. A global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality-of-life burden. menopause2021;28:875-882.

7 Depypere H, Timmerman D, Donders G, et al. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. J Clean Endocrinol metabolism. 2019; 104:5893-5905.

8 Fraser GL, Lederman S, Waldbaum A, et al.phase 2bA randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fesolinetant for vasomotor symptoms associated with menopause. menopause2020;27:382-392.

9 Fraser GL, Hoveyda HR, Clarke IJ, et al. ESN364, an NK3 receptor antagonist, blocks pulsatile LH secretion and moderate levels of ovarian hormone throughout the menstrual cycle. endocrinology2015;156:4214-4225.

SOURCE Astellas Pharma Inc.

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