Astellas Reports the Submission of NDA to the US FDA for Fezolinetant to Treat Vasomotor Symptoms Associated with Menopause
- The company has submitted an NDA to the US FDA for fezolinetant in patients with mod. to sev. VMS associated with menopause
- The NDA submission was based on the P-III (SKYLIGHT 1 & 2) in 1000 women for the first 12wks. followed by a 40wk. treatment extension period along with the P-III (SKYLIGHT 4) study in 1800 women for 52wk. evaluating fezolinetant to treat mod. to sev. VMS at ~180 sites within the US, Canada & EU
- Fezolinetant is an oral, nonhormonal compound indicated for VMS associated with menopause & blocks NKB binding on the KNDy neuron to mod. neuronal activity in the thermoregulatory center of the brain to reduce the frequency & severity. The financial effects of this submission for Mar 2023 are being assessed by Astellas
Ref: Astellas | Image: Astellas
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