Astellas Pharma’s menopause drug just got FDA approval

The US Food and Drug Administration has approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause.

Veozah of Astellas Pharma US, Inc. is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes due to menopause. It works by binding to and blocking the activity of NK3 receptors, which play a role in regulating body temperature in the brain.

“Hot flashes due to menopause can be a serious physical burden on women and affect their quality of life,” said Janet Maynard, director of the Office of Rare Diseases, Pediatrics, Urology, and Reproductive Medicine, at 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 a safe and effective additional treatment option for women.”

Astellas drugs target nerve activity

Menopause is a normal and natural change in a woman’s life when menstruation stops, usually occurring between the ages of 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 about 80% of postmenopausal women and can include periods of sweating, flushing, and chills that last 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 therapy. Veozah is not a hormone. It targets the nerve activity that causes hot flashes during menopause.

The effectiveness of Veozah for treating moderate to severe hot flashes was demonstrated in the first 12 weeks each, a randomized, placebo-controlled, double-blind section of two phase 3 clinical trials.

In both trials, after the first 12 weeks, women who were on placebo were then randomized back into Veozah for an extended 40-week study to evaluate safety. Each trial ran a total of 52 weeks. The mean age of trial participants was 54 years.

Results of a landmark phase 3 trial for the fezolinetant, published in The Lancet, were published in March, with the study meeting all four coprimer efficacy endpoints.

The approval follows an announcement last year by US startup Oviva Therapeutics, which said it aimed to develop a hormone therapy that could delay menopause as part of the aging process.