FDA To Review Astellas' Fezolinetant New Drug Application, Decision Expected In Feb.

Japanese drug maker Astellas Pharma Inc. (ALPMY,ALPMY) said on Thursday that its New Drug Application for Fezolinetant has been accepted for review by the FDA.

Fezolinetant is an investigational oral, non-hormonal, selective neurokinin 3 receptor antagonist proposed for the treatment of moderate to severe vasomotor symptoms associated with menopause.

The FDA is expected to announce its decision on Fezolinetant on February 22, 2023, following use of a priority review voucher (PRV).

Astellas has recorded 13.1 billion yen of amortization of the intangible asset related to PRV as R&D expense for the first quarter.

For the year to March 31, 2023, the company said that the impact of the drug regulator's clearance is expected to be limited.

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