Astellas :Phase 3 Trial Of Fezolinetant Shows Positive Results For Treatment Of VMS Due To Menopause

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) announced positive results from the Phase 3b DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms or VMS due to menopause.

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

The study, comprised of more than 450 women considered unsuitable for hormone therapy, met the primary objective showing statistically significant reduction from baseline in the frequency of moderate to severe VMS to week 24 for fezolinetant 45 mg once daily versus placebo.

The company noted that serious treatment emergent adverse events (TEAE) occurred in less than 5% of patients, and the most common TEAEs were COVID-19 and headache. Detailed results will be submitted for publication and for consideration at an upcoming medical meeting.

Fezolinetant was approved as VEOZAH by the U.S. Food and Drug Administration in May 2023, and Astellas is pursuing regulatory approval for fezolinetant in several other countries and regions, including Europe.