Astellas remains confident in fezolinetant despite FDA delay

Japanese drugmaker Astellas (TSE: 4503) closed Monday’s trading 2% lower following some news on fezolinetant, its investigational agent for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.

The US Food and Drug Administration (FDA) has notified the company that it is extending the original priority review Prescription Drug User Fee Act (PDUFA) goal date for the oral, NK3 receptor antagonist by three months, to May 22, 2023, to allow more time for the agency to complete its review.

Ahsan Arozullah, senior vice president and head of Development Therapeutic Areas, Astellas, said: “We remain confident in the clinical profile of fezolinetant and the potential benefits it could bring to women experiencing moderate to severe VMS due to menopause, and we will continue to work with the FDA on its review of the NDA for fezolinetant.”