On May 12, 2023, the U.S. Food and Drug Administration (FDA) announced the approval of AstellasPharma’s Veozah (fezolinetant) for the treatment of moderate to severe hot flashes related to menopause. Hot flashes, also known as vasomotor symptoms, are episodes of flushing, sweating and chills that can last several minutes. These episodes affect 80% of menopausal women and can impair their quality of life. Symptoms are related to the declining production of hormones estrogen and progesterone during menopause. Hormone replacement therapy (HRT) has been the standard treatment for women experiencing hot flashes, but unfortunately not all women are candidates. Veozah® is not a hormone therapy, thereby offering a safe and effective alternative for menopausal women with a history of blood clots, stroke, liver disease or heart attack who are unable to safely take HRT.
Veozah® is a medication that blocks the neurokinin 3 (NK3) receptor which helps in the regulation of body temperature. It is a once daily oral medication that should be taken at the same time each day, with or without food. The most reported side effects of Veozah® include diarrhea, abdominal pain, back pain and elevated liver enzymes. Veozah® was tested in two randomized, double-blind, placebo-controlled phase 3 clinical trials. Each trial ran for 52 weeks with the average age of participants being 54. In the first 12 weeks of each study, Veozah® showed a significant reduction in frequency of hot flashes from participants’ baseline. The following 40 weeks were utilized to evaluate safety of treatment and duration of effect. The prescribing information for Veozah® includes a warning for liver injury, so patients should receive bloodwork to review liver function prior to treatment. For the first 9 months of treatment, this bloodwork should be repeated every 3 months. Patients are also advised to self-monitor for possible signs and symptoms related to liver damage, such as nausea, vomiting or yellowing of the skin or eyes. Veozah® was granted Priority Review designation by the FDA.