The Food and Drug Administration has approved fezolinetant (Veozah), an oral medication for the treatment of moderate to severe hot flashes in menopausal women. The approved dose is 45 mg once daily.
Fezolinetant, a neurokinin 3 (NK3) receptor antagonist, is the first drug of its kind to earn FDA approval for the vasomotor symptoms associated with menopause, according to the agency. The drug binds to the NK3 receptor, which plays a role in regulating body temperature, and blocks its activity.
Fezolinetant is not a hormone and can be taken by women for whom hormones are contraindicated, such as those with a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease, the FDA said.
The approval was based on data from the SKYLIGHT 2 trial, results of which were presented at the annual meeting of the Endocrine Society, reported by Medscape and published in the Journal of Clinical Endocrinology and Metabolism.
In the two-phase trial, women were randomly assigned to receive either 30 mg or 45 mg of fezolinetant or placebo. After 12 weeks, women in placebo groups were re-randomized to fezolinetant for a 40-week safety study.
The study population included women aged 40-65 years, with an average minimum of seven moderate-to-severe hot flashes per day. The study included 120 sites in North America and Europe.
At 12 weeks, both placebo and fezolinetant patients experienced reductions in moderate to severe vasomotor symptoms of approximately 60%, as well as a significant decrease in vasomotor symptom severity.
The FDA statement noted that patients should undergo baseline blood work before starting fezolinetant to test for liver infection or damage, and the prescribing information includes a warning for liver injury; blood work should be repeated at 3, 6, and 9 months after starting the medication, according to the FDA and the manufacturer, Astellas.
The most common side effects associated with fezolinetant include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver values, according to the FDA statement. The FDA granted Astellas Pharma’s application a Priority Review designation.
Astellas plans to charge $500 for a 30-day supply of fezolinetant, according to Endpoints News. That figure, which amounts to about $6000 annually, is significantly higher than a previous recommendation of between $2000 and $2500 per year, the outlet reported.
Heidi Splete is a journalist in Maryland.
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