- In May 2023, Astellas Pharma Inc. achieved a significant milestone with the FDA approval of VEOZAH (fezolinetant), making it the first non-hormonal neurokinin 3 (NK3) receptor antagonist specifically approved for the treatment of moderate to severe VMS associated with menopause. This oral, once-daily medication offers a novel mechanism of action, addressing a critical unmet need for women who cannot or prefer not to use hormonal therapies. Clinical trials (SKYLIGHT 1 and SKYLIGHT 2) demonstrated its efficacy in significantly reducing the frequency and severity of hot flashes
- In March 2023, The Lancet published results from Astellas' pivotal Phase 3 SKYLIGHT 1™ study of fezolinetant, further solidifying its efficacy and safety profile for VMS treatment. The successful publication of such robust clinical data provides crucial evidence supporting the adoption of new non-hormonal options by healthcare providers and patients, influencing market dynamics
- In June 2023, Astellas Pharma Inc. announced positive topline results from the Phase 3b DAYLIGHT clinical trial for fezolinetant. This study specifically evaluated the 24-week efficacy and safety in more than 450 women considered unsuitable for hormone therapy, showing a statistically significant reduction in VMS frequency. This further expands the evidence base for fezolinetant, addressing a specific patient population within the VMS market
