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. 
  • Price Action: ALPMF shares are trading $16.25 during the market session on the last check Monday.
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