Phase III long-term study confirms safety of Astellas fezolinetant

Japanese pharma major Astellas (TYO: 4503) today released positive 52-week results from the Phase III SKYLIGHT 4 clinical study evaluating the safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

The full results will be featured in an oral presentation October 13 at The North American Menopause Society Annual Meeting.

SKYLIGHT 4 results demonstrate the 52-week safety and tolerability of fezolinetant 30mg and 45mg once daily. Safety analyses demonstrated that both endometrial hyperplasia and endometrial malignancy were within pre-specified limits for fezolinetant-treated patients; reported treatment-emergent adverse events (TEAEs) were generally mild or moderate in severity; and headache and COVID-19 were the most common TEAEs, with similar incidences for fezolinetant and placebo. The frequency of elevated liver enzymes was low across groups, and elevations were generally asymptomatic, isolated, transient and resolved on treatment or soon after study drug discontinuation.