The US Food and Drug Administration has approved Veozah (fezolinetant), an oral drug developed by Astellas Pharma for the treatment of moderate to severe hot flashes associated with menopause. The drug taken once a day at a dose of 45 mg is able to reduce the frequency and severity of menopausal hot flashes “with a new mechanism of action” as recalled Marci English, Vice President and Head of Development, BioPharma, Astellas. It is a fist-in-class neurokinin 3 (Nk3) receptor antagonist, which works by binding to and blocking the activities of the Nk3 receptor, which plays a role in the brain’s regulation of body temperature. Different from the hormonal treatments used so far which can be contraindicated in some situations.
Hot flashes
Before menopause, there is a balance between estrogen (hormones produced by a woman’s ovaries) and neurokinin B (Nkb), a brain chemical. This balance regulates the body’s temperature control center located in a specific area of the brain. As the body goes through menopause, estrogen decreases and this balance is disrupted. Which can lead to invasive symptoms such as hot flashes occur in about 80% of menopausal women and can include periods of sweating, hot flashes and chills that last for several minutes. Fezolinetant is able to restore balance by blocking Nkb in the temperature control center to reduce the number and intensity of hot flashes.
A milestone
“Hot flashes due to menopause can place a serious physical burden on women and impact their quality of life,” she said. Janet Maynard, director of the Office of rare diseases, pediatrics, urologic and reproductive medicine at the FDA’s Center for Drug Evaluation and Research. They are indeed the common symptoms of menopause for which women seek treatment.
Per Genevieve Neal-Perry, Chair, Unc School of Medicine Department of Obstetrics and Gynecology The approval of fezolinetant is a significant, long-awaited milestone for people experiencing moderate to severe vasomotor symptoms during the menopausal transition. “The therapy is based on our understanding of the biology behind hot flashes,” she explained. “I am thrilled to hear that patients will have the option to choose this non-hormonal treatment.”
registration studies
The approval is supported by results from the Bright Sky program, which includes three randomized, placebo-controlled, double-blind, Phase 3 clinical trials as part of a development program that collectively enrolled more than 3,000 people in the United States, Canada and in Europe. Specifically in the pivotal Skylight 1 and 2 studies after the first 12 weeks, placebo-treated women were then re-randomized to Veozah for a 40-week extension study to assess safety. Each trial had a total duration of 52 weeks. The mean age of the study participants was 54 years. The FDA has granted the Veozah application Priority Review designation.