BREAKING: Fezolinetant news

Patience, hot flashers

Looks like women in the US have to wait a little longer for another option to deal with hot flashes.

Astellas Pharma has announced that the US Food and Drug Administration is extending the original priority review Prescription Drug User Fee Act goal date for fezolinetant, its promising new investigational non-hormonal therapy for hot flashes.

According to a previous release, Astellas was expecting to news about fezolinetant on February 22, a goal date that has now been extended by three months to May 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.

Meanwhile, the Institute for Clinical and Economic Review, a US medicines effectiveness watchdog, has released a report “finding that the ev…