Positive new data on Astellas' fezolinetant

Positive12-week results (S-13) from the pivotal Phase III SKYLIGHT 2 clinical trial of fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause were presented on Friday at the North American Menopause Society 2021 Annual Meeting in Washington DC, by Japanese pharma major Astellas Pharma (TYO: 4503).

VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause. The global hormone replacement market is forecast to reach a value of $22.31 billion by 2020.

Findings showed fezolinetant 30mg and 45mg administered once-daily met the co-primary endpoints of the study, demonstrating a statistically-significant reduction from baseline in the frequency and severity of moderate to severe VMS at weeks 4 and 12 versus placebo. Results also showed that improvement in VMS frequency and severity greater than placebo was observed through the 12-week placebo-controlled period, with improvement observed as early as one week after treatment onset for both doses.