ALPMY - FDA extends review period of Astellas fezolinetant to treat menopause symptoms
- The U.S. Food and Drug Administration (FDA) extended review period by three months of Astellas Pharma's ( OTCPK:ALPMF ) ( OTCPK:ALPMY ) fezolinetant to treat moderate to severe vasomotor symptoms (VMS) due to menopause.
- The company said the FDA needed more time to review the new drug application, which had received priority review in August 2022 with a decision expected by Feb. 22.
- "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," said Ahsan Arozullah, senior vice president and head of Development Therapeutic Areas, Astellas.
- Astellas expects the impact of this matter on its financial results of fiscal year ending March 31 to be minor.
- VMS, commonly called hot flashes or flushes and night sweats, are common symptoms of menopause.
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FDA extends review period of Astellas fezolinetant to treat menopause symptoms