Astellas' Menopause Drug Sores FDA Approval, After Regulatory Setback

The FDA on Friday approved Japanese drugmaker Astellas Pharma Inc’s ALPMY ALPMF Veozah (fezolinetant) for hot flashes associated with menopause.

Hormonal changes during menopause make the body more sensitive to fluctuations in body temperature, causing so-called vasomotor symptoms, or hot flashes and night sweats.

Vasomotor symptoms, or hot flashes and night sweats, are common symptoms of menopause. Some 60% to 80% of women experience the symptoms during or after menopausal transition, Astellas said.

Reuters noted that Astellas said that the drug’s wholesale acquisition cost is $550 for a 30-day supply, and it is expected to be available in pharmacies within three weeks.

Some women who experience hot flashes and have a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease cannot take hormone therapies. 

Veozah is not a hormone. It targets the neural activity which causes hot flashes during menopause. 

The prescribing information for Veozah includes a warning for elevated hepatic transaminase or liver injury. Before using Veozah, patients should have blood work done to test for liver damage.

It’s been a bit of a bumpy road to the green light for Astellas to bring its menopause drug candidate fezolinetant to market. It hit a last-minute snag as FDA extended the review by three months just days before the approval decision date.

The PDUFA target action date of February 22, 2023, followed the use of a priority review voucher. Astellas booked ¥13.1 billion of amortization of the intangible asset relating to PRV as R&D expense in Q1 FY22.

In March last year, after acing a pair of phase 3 trials, Astellas Pharma reported the failure of fezolinetant to beat a placebo in a late-stage study of patients in Asia.