Astellas to Present Findings from Phase 3 Long-Term Safety Study of Fezolinetant in Oral Session at The North American Menopause Society 2022 Annual Meeting

SKYLIGHT 4™ study results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg once daily

Pooled analyses will also be presented from SKYLIGHT 1™ and SKYLIGHT 2™ studies of fezolinetant, Astellas' investigational nonhormonal treatment for vasomotor symptoms (VMS) associated with menopause

TOKYO, Oct. 12, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") will present 52-week results from the Phase 3 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 results will be featured in an oral presentation October 13 at The North American Menopause Society Annual Meeting. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2

SKYLIGHT 4 results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg 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.