Astellas' fezolinetant hits Phase III goals for VMS

Japanese drug major Astellas Pharma (TYO: 4503) has announced positive top-line results from the Phase III pivotal SKYLIGHT 1 and SKYLIGHT 2 clinical trials for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS), ie, hot flashes associated with menopause.

Fezolinetant came to Astellas with its $856 million acquisition of Belgian firm Ogeda in 2017.

Both trials met all four co-primary endpoints showing statistically-significant reduction from baseline in the frequency and severity of moderate to severe VMS to week four and week 12 for women who received fezolinetant 30mg and 45mg once-daily (QD) versus placebo.