FDA Approves Fezolinetant, A Novel Therapy for Vasomotor Symptoms in Menopause

The FDA has approved fezolinetant (Veozah), an oral medication to treat moderate to severe vasomotor symptoms caused by menopause, according to an agency press release.¹ This is the first neurokinin 3 (NK3) receptor antagonist approved for this condition.

Vasomotor symptoms are characterized by hot flashes and/or night sweats and are the most common symptoms of menopause that lead to women seeking treatment.² According to a press release from manufacturer Astellas, approximately 60% to 80% of women in the United States experience these symptoms “during or after the menopausal transition,” which can disrupt a woman’s daily activities and negatively impact her overall quality of life.

The balance between estrogen and neurokinin B work to regulate the body’s temperature control center. However, during menopause, estrogen declines and the balance is disrupted. This imbalance is what leads to vasomotor symptoms, which fezolinetant helps re-balance by blocking neurokinin B in the brain’s temperature control center.

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, MD, MHS, 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.”

Fezolinetant effectiveness was demonstrated through the Bright Sky Phase 3 program, which included the SKYLIGHT 1 (NCT04003155) and SKYLIGHT 2 (NCT04003142), each of which enrolled over 1000 participants (mean age, 54 years) experiencing moderate to severe vasomotor symptoms. These trials each included a 12-week double-blinded, placebo-controlled phase followed by a 40-week treatment extension period. SKYLIGHT 4 (NCT04003389) is a 52-week, double-blind, placebo-controlled study designed to evaluate the long-term safety of the drug.

Patients taking fezolinetant should take one 45 mg pill by mouth once daily, at the same time each day, with or without food. Fezolinetant prescribing information includes a warning for elevated hepatic transaminase. Prior to beginning treatment, and every 3 months for the first 9 months of treatment, patients should have bloodwork done to test for liver damage. This medication cannot be used with CYP1A2 inhibitors.

“Today’s approval of fezolinetant is a significant and…long awaited milestone for individuals in the US who experience moderate to severe vasomotor symptoms during the menopausal transition,” said Genevieve Neal-Perry, MD, PhD, chair of the UNC School of Medicine Department of Obstetrics and Gynecology. “I’m excited to know that patients will have the option to choose this nonhormonal treatment.”

References

1. FDA approves novel drug to treat moderate to severe hot flashes caused by menopause. News release. FDA. May 12, 2023. Accessed May 12, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause

2. Astellas’ Veozah (fezolinetant) approved by US FDA for treatment of vasomotor symptoms due to menopause. News release. Astellas Pharma Inc. May 12, 2023. Accessed May 12, 2023. https://newsroom.astellas.us/2023-05-12-Astellas-VEOZAH-TM-fezolinetant-Approved-by-U-S-FDA-for-Treatment-of-Vasomotor-Symptoms-Due-to-Menopause