US FDA Accepts New Drug Application of Astellas for Fezolinetant


The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) of Astellas Pharma Inc. for fezolinetant, an investigational oral, nonhormonal compound that is seeking approval for the treatment of moderate to serious vasomotor symptoms (VMS) that are associated with menopause.

VMS, which is characterized by hot flashes and night sweats, is the common symptoms of menopause. Astellas Pharma Inc. has booked amortization of the intangible asset that is related to PRV as research and development expense in the first quarter of 2022.

Ahsan Arozullah, senior vice president and head of development therapeutic areas of Astellas, said the acceptance of US FDA of their NDA for fezolinetant brings them one step closer to advancing care for women in the United States.

Ahsan Arozullah said they now look forward to the review by the US FDA of their application, and the potential to offer a nonhormonal treatment option to decrease the frequency and seriousness of moderate to severe VMS associated with menopause.

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This New Drug Application (NDA) is supported by results from the BRIGHT SKY program that included three phase 3 clinical trials, which collectively enrolled more than 2,800 women with VMS across Canada, the United States, and Europe.

Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist, and the efficacy and safety of fezolinetant are now under investigation and are not established.