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The FDA on Friday approved Japanese drugmaker Astellas Pharma Inc’s (OTC:ALPMY) (OTC: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.
