The U.S. Food and Drug Administration has approved Astellas Pharma’s Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause.
Astellas Pharma US, Inc.’s Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.
“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research.
“The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”
Astellas Pharma’s drug targets neural activity
Menopause is a normal, natural change in a woman’s life when her period stops, usually occurring between ages 45 and 55.
During menopause, a woman’s body slowly produces less of the hormones estrogen and progesterone. A woman has reached menopause when she has not had a menstrual period for 12 consecutive months. Hot flashes occur in around 80% of menopausal women and can include periods of sweating, flushing and chills lasting for several minutes.
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 that causes hot flashes during menopause.
The effectiveness of Veozah to treat moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two phase 3 clinical trials.
In both trials, after the first 12 weeks, the women on placebo were then re-randomized to Veozah for a 40-week extension study to evaluate safety. Each trial ran a total of 52 weeks. The average age of the trial participants was 54 years old.
The pivotal phase 3 trial results for fezolinetant, which were published in The Lancet, were published in March, with the study meeting all four coprimary efficacy endpoints.
This approval follows on from last year’s announcement by the U.S. startup Oviva Therapeutics, which said it was aiming to develop hormonal therapies that can delay menopause as part of the aging process.