- After acing a pair of phase 3 trials, Astellas Pharma Inc (OTC:ALPMF) has reported the failure of fezolinetant to beat placebo in a late-stage study of patients in Asia.
- The study randomized 302 women in China, Korea, and Taiwan.
- After 12 weeks, Astellas saw numerical improvements in the rate of hot flashes from baseline in the fezolinetant arm, but the difference from placebo fell short of statistical significance.
- Fezolinetant is yet to share 24-week data from the study. The one positive is that the 12-week safety data are in line with the results of earlier trials.
- Related: Astellas Touts Safety Data For Phase 3 Menopause Drug, Sets Up US Filing.
- As previously reported, the results from two Phase 3 trials, SKYLIGHT 1 and SKYLIGHT 2, along with the findings from the long-term safety study, SKYLIGHT 4, will provide the foundational data for regulatory submissions in the U.S. and Europe.
- Also See: Astellas Pharma's Fezolinetant Topped Placebo For Reducing Severity Of Menopausal Hot Flash In Phase 3 Studies.
- Price Action: ALPMF shares are trading at $15.81 during the market session on the last check Tuesday.
