Astellas : EMA Accepts Marketing Authorization Application For Fezolinetant

Astellas Pharma Inc. said that the European Medicines Agency or EMA has accepted for regulatory review the company's marketing authorization application or MAA for fezolinetant, an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms or VMS associated with menopause.

VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.

If authorized by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause, the company said.

The marketing authorization application is supported by results from the BRIGHT SKY program, which included three Phase 3 trials that collectively enrolled over 2,800 women with VMS across Europe, the U.S. and Canada.

Results from the SKYLIGHT 1 and SKYLIGHT 2 pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. Within the MAA, Astellas proposes a 45 mg daily dose, which is subject to the EMA's review.

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