Astellas’ Veozah (fezolinetant) Receives the US FDA’s Approval for the Treatment of Vasomotor Symptoms Due to Menopause
- The US FDA has approved Veozah (45mg, qd) for the treatment of mod. to sev. vasomotor symptoms (VMS) due to menopause. The approval was based on the results from the (BRIGHT SKY) program incl. three P-III clinical trials as part of a development program in ~3,000 patients across the US, Canada, and EU
- In (SKYLIGHT 1 & 2) trials, results emphasized the safety and efficacy of fezolinetant for the treatment of VMS associated with menopause. while (SKYLIGHT 4) demonstrated the long-term safety of fezolinetant
- Additionally, the MAA for fezolinetant is also under regulatory review in the EU, Switzerland, and Australia
Ref: Astellas | Image: Astellas
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