FDA Accepts Astellas’ New Drug Application for Fezolinetant

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for 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). Astellas booked ¥13.1 billion of amortization of the intangible asset relating to PRV as R&D expense in the first quarter of fiscal year 2022.

“The FDA’s acceptance of our NDA for fezolinetant brings us one step closer to advancing care for women in the U.S. who experience VMS,” said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. “We look forward to the FDA’s review of our application, and the potential to offer a first-in-class nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause.”

The NDA is supported by results from the BRIGHT SKY program, which included three Phase 3 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.

The impact of this acceptance on Astellas’ financial results of the current fiscal year ending March 31, 2023, is expected to be minor.