The Food and Drug Administration (FDA) has approved Veozah™ (fezolinetant) for the treatment of moderate to severe vasomotor symptoms due to menopause.
Fezolinetant, an oral neurokinin 3 (NK3) receptor antagonist, works by blocking neurokinin B binding on the kisspeptin/neurokinin/dynorphin neuron to regulate neuronal activity in the thermoregulatory center. The approval was based on the BRIGHT SKY program, which included efficacy and safety data from the pivotal phase 3 SKYLIGHT 1 (ClinicalTrials.gov: NCT04003155) and 2 (ClinicalTrials.gov: NCT04003142) studies, along with the SKYLIGHT 4 safety study (ClinicalTrials.gov: NCT04003389).
The randomized, double-blind, placebo-controlled SKYLIGHT 1 and 2 studies evaluated the efficacy and safety of fezolinetant (30mg and 45mg) orally once daily in 1022 women aged 40 to 65 years with moderate to severe vasomotor symptoms. The first 12 weeks of each trial were double-blinded and placebo-controlled and were followed by a 40-week active treatment extension period.
Findings from both trials showed statistically significant and clinically meaningful (≥2 hot flashes over 24 hours) reduction from baseline in the frequency of moderate to severe vasomotor symptoms with fezolinetant 45mg compared with placebo at weeks 4 and 12. The 45mg dosage strength was also associated with a statistically significant reduction from baseline in the severity of moderate to severe vasomotor symptoms (over 24 hours) compared with placebo at weeks 4 and 12.
The most common adverse reactions reported with fezolinetant were abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation. Fezolinetant is contraindicated in women with known cirrhosis, severe renal impairment or end-stage renal disease, or with concomitant CYP1A4 inhibitors.
“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.”
Veozah is supplied as 45mg tablets in 30- and 90-count bottles. The treatment is taken once a day at the same time each day. The product is expected to be available within the next 3 weeks.
- FDA approves novel drug to treat moderate to severe hot flashes caused by menopause. News release. US Food and Drug Administration. Accessed May 12, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause?utm_medium=email&utm_source=govdelivery.
- Astellas’ Veozah™ (fezolinetant) approved by US FDA for treatment of vasomotor symptoms due to menopause. News release. Astellas Pharma Inc. 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.
- Package Insert. Astellas Pharma Inc.; 2023. Accessed May 12, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216578s000lbl.pdf.