More positive data for Astellas VMS treatment fezolinetant

Adding to strong data released earlier this year form the SKYLIGHT 2 and SKYLIGHT 4 studies, Japanese drug major Astellas (TYO: 4503) today announced positive top-line results from the Phase IIIb DAYLIGHT clinical trial for fezolinetant.

Fezolinetant is an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (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 45mg once daily versus placebo. 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.