Astellas Touts Safety Data For Phase 3 Menopause Drug, Sets Up US Filing

Astellas Pharma Inc ALPMF announced topline results from the Phase 3 SKYLIGHT 4 trial investigating the long-term safety of fezolinetant in vasomotor symptoms associated with menopause (VMS).
The data will support future regulatory filing submissions.
The study has met its primary objectives, including safety and tolerability and improvements in endometrial health at week 52.
The most common adverse events were headache and COVID-19, which matched the placebo arm.
The topline results come from the phase 3 trial called Skylight 4, which examined the long-term safety of nonhormonal menopause treatment fezolinetant.
The study featured 1,800 women with moderate-to-severe vasomotor symptoms of menopause, such as hot flashes and night sweats.
The readout will be used to inform future regulatory filings in the U.S. and EU, Astellas said.
Also included in the future data package will be results from two other late-stage pivotal trials, Skylight 1 and Skylight 2, the latter of which previously found that fezolinetant reduced the frequency and severity of menopause symptoms.
Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist.
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