Astellas Pharma Inc. (OTC:ALPMY) said today that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for Fezolinetant, an oral, non-hormonal compound that is being tested to treat moderate to severe vasomotor symptoms (VMS) caused by menopause. Symptoms of menopause often include VMS, which is marked by hot flashes and/or night sweats. 1,2
After using a priority review voucher, the PDUFA target action date is February 22, 2023. (PRV). Astellas’s (OTC:ALPMY) R&D spend for the first quarter of fiscal year 2022 was comprised of 13,1 billion of PRV-related intangible asset amortization.
Astellas’ (OTC:ALPMY)Senior Vice President and Head of Development Therapeutic Areas, Ahsan Arozullah, M.D., M.P.H., stated, The FDA’s acceptance of our New Drug Application for Fezolinetant puts us one step closer to expanding therapy for U.S. women with VMS. We anticipate the FDA’s consideration of our application, and the possibility of offering a first-of-its-kind nonhormonal therapeutic option to lessen the frequency and severity of moderate to severe VMS associated with menopause.
The NDA is supported by the outcomes of the BRIGHT SKYTM program, which included three Phase 3 clinical trials that cumulatively included more than 2,800 women with VMS in the United States, Canada, and Europe. The efficacy and safety of Fezolinetant for the treatment of moderate to severe VMS associated with menopause have been characterized by the SKYLIGHT 1TM and SKYLIGHT 2TM pivotal trials. The long-term safety profile of Fezolinetant is further characterized by data from the SKYLIGHT 4TM safety study. In the NDA, Astellas (OTC:ALPMY) proposes a 45 mg daily dose, which is subject to assessment by the FDA.
Fezolinetant is a nonhormonal, selective antagonist of the neurokinin 3 (NK3) receptor that is under research. The safety and effectiveness of fFzolinetant are under investigation and have not yet been confirmed.
It is anticipated that this acceptance will have little effect on the financial performance of Astellas (OTC:ALPMY) for the current fiscal year, which ends on March 31, 2023.
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