Shots:
The EMA has accepted the MAA of fezolinetant for regulatory review to treat VMS in patients associated with menopause
The MAA was based on the BRIGHT SKY program incl. 3 P-III (SKYLIGHT 1/2/4) trials evaluating fezolinetant in ~2,800 women with VMS at ~180 sites within the US, Canada & EU
The results from the (SKYLIGHT 1 & 2) trials characterize the efficacy & safety of fezolinetant for the first 12wks, followed by a 40wk. treatment extension period while the (SKYLIGHT 4) safety study further characterizes the long-term safety profile. If EC authorized fezolinetant, it will be a nonhormonal treatment for mod. to sev. vasomotor symptoms associated with menopause
Ref: PRNewswire | Image: Astellas
