Astellas Reports Positive Results From Phase 3 Study Of Fezolinetant On Vasomotor Symptoms

Astellas Pharma Inc. (ALPMY,ALPMY) announced topline results from the long-term phase 3 safety study of fezolinetant which inform future regulatory filings for the treatment of moderate to severe vasomotor symptoms associated with menopause or VMS.

VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.

The study is a randomized, placebo-controlled, double-blind Phase 3 clinical trial in over 1,800 women investigating the long-term (52-week) safety of fezolinetant in women seeking treatment for relief of VMS associated with menopause.

The study's primary objectives were to evaluate the effect of fezolinetant on endometrial health and the long-term safety and tolerability of fezolinetant.

The primary endpoint assessing endometrial health was achieved and the most common treatment emergent adverse events (TEAE) were headache and COVID-19, consistent with placebo.

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