FDA green light for novel drug to treat menopausal hot flashes

The US Food and Drug Administration on Friday finally approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause.

The FDA granted the Veozah application, submitted by the US subsidiary of Japanese pharma major Astellas (TYO: 4503), Priority Review designation. The news came well after Japan’s stock markets stopped trading, but Astellas’ shares gained 2.2% to 2,176 yen today.

In February this year, the FDA delayed its decision on the drug, extending the original priority review Prescription Drug User Fee Act (PDUFA) goal date from February 22 to May 22, 2023, to allow more time for the agency to complete its review.