Astellas to Present P-III (SKYLIGHT 4) Study of Fezolinetant for Vasomotor Symptoms Associated with Menopause at NAMS 2022
Shots:
- The P-III (SKYLIGHT 4) study evaluating fezolinetant (30/45mg, qd), showed the 52wk. safety & tolerability of fezolinetant
- The safety analyses demonstrated that endometrial hyperplasia & endometrial malignancy were within pre-specified limits, the frequency of increased liver enzymes was low across groups, and these increases were often asymptomatic, isolated, transient and resolved
- The pooled efficacy data will also be presented from (SKYLIGHT 1 & 2) studies that evaluate early response to fezolinetant, its impact on sleep, and treatment response. The NDA & MAA for fezolinetant are under the US FDA & EMA review and if fezolinetant is approved, it will be a first-in-class, nonhormonal treatment option to reduce the frequency & severity
Ref: Astellas | Image: Astellas
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