Astellas fezolinetant to treat menopause symptoms gets FDA review

Headquarters of US Food and Drug Administration (FDA)


The U.S. Food and Drug Administration (FDA) accepted to review Astellas Pharma’s (OTCPK:ALPMF) (OTCPK:ALPMY) application seeking approval of fezolinetant to treat moderate to severe vasomotor symptoms (VMS) associated with menopause.

The FDA is expected to make a decision on the New Drug Application (NDA) by Feb. 22, 2023.

The Japanese drugmaker used a priority review voucher (PRV), due to which the drug will get an expedited review. Under priority review, the FDA’s goal is to take action within six months, compared to 10 months under standard review.

The company said the NDA was backed by data from BRIGHT SKY program, which included three phase 3 trials which collectively enrolled over 2,800 women with VMS across the U.S., Canada and Europe.

VMS, commonly called hot flashes or flushes and night sweats are common symptoms of menopause.

“We look forward to the FDA’s review of our application, and the potential to offer a first-in-class nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause,” said Ahsan Arozullah, senior vice president and head of Development Therapeutic Areas, Astellas.

Astellas added that it booked ¥13.1B of amortization of the intangible asset relating to PRV as R&D expense in the first quarter of fiscal year 2022.

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