The FDA approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. 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.
Menopause is a normal, natural change in a woman’s life when her period stops, usually occurring between ages 45 and 55. Menopause is often referred to as “the change of life” or “the change.” 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 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 or infection. While on Veozah, routine bloodwork should be performed every three months for the first nine months of using the medication. Patients experiencing symptoms related to liver damage—such as nausea, vomiting, or yellowing of the skin and eyes—should contact a physician. Veozah cannot be used with CYP1A2 inhibitors. Patients with known cirrhosis, severe renal damage or end-stage renal disease should not take Veozah.
The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases.
The FDA granted the Veozah application Priority Review designation. The approval of Veozah was granted to Astellas Pharma US, Inc.
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