FDA accepts NDA for ESN 364 in vasomotor symptoms with menopause
Astellas Pharma announced that the FDA has accepted the company's New Drug Application (NDA) for ESN 364 (fezolinetant), an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause
VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause. The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV).
The NDA is supported by results from the BRIGHT SKY program, which included three Phase III clinical trials that collectively enrolled over 2,800 women with VMS across the U.S., Canada and Europe. Results from the SKYLIGHT 1 and SKYLIGHT 2 pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. Within the NDA, Astellas proposes a 45 mg daily dose, which is subject to the FDA's review.
Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established.
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