VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2
'More than half of women 40 to 64 years of age experience hot flashes during menopause, with limited nonhormonal treatment options,' said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. 'The EMA's acceptance of our MAA for fezolinetant brings us one step closer to advancing a potential first-in-class nonhormonal treatment option for women in
The MAA 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
Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established.
This acceptance will have no impact on Astellas' financial forecasts of the current fiscal year ending
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 trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the
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 with rates in
About Fezolinetant
Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe 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. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.
About Astellas
Cautionary Notes
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. 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. 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. 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.
Contact:
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Email: anna.otten@astellas.com
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