Astellas Announces Positive Phase 3b DAYLIGHT Trial Results for Veozah (fezolinetant) in Menopausal Vasomotor Symptoms

▎WuXi

Edited by Kant Content Team

Recently, Astellas Pharma announced positive results from the Phase 3b DAYLIGHT clinical trial. The trial evaluated its oral medication Veozah (fezolinetant) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause in women considered unsuitable for hormone therapy. VMS, characterized by hot flashes and/or night sweats, is a common symptom of menopause. Analysis shows,At Week 24, the frequency and severity of moderate to severe VMS due to menopause and patient-reported sleep disturbances showed a statistically significant reduction.Detailed data were presented at the 2023 European Society of Gynecology (ESG) Congress.

The trial enrolled more than 450 women who were considered unsuitable for hormone therapy and met all primary and secondary endpoints at 24 weeks.On the primary endpoint of mean change from baseline in moderate to severe VMS frequency, 45mg fezolinetant showed a statistically significant reduction of 1.93 compared to placebo (p<0.001).In the key secondary endpoint of mean change from baseline in moderate to severe VMS severity, analysis showed that, compared with placebo, fezolinetant demonstrated a statistically significant reduction of 0.39 (p<0.001).In the secondary endpoint of mean change from baseline in patient-reported sleep disturbances, fezolinetant showed a statistically significant reduction of 2.5 compared to placebo (p<0.001).

TEAEs Reported by 65% of Patients in the Fezolinetant Group and 61% in the Placebo GroupThe most common TEAEs were COVID-19 (13.3% in the fezolinetant group vs. 12.8% in the placebo group), headache (8.8% in the fezolinetant group vs. 9.3% in the placebo group), and fatigue (5.8% in the fezolinetant group vs. 0.4% in the placebo group). Serious TEAEs occurred in 4.4% of patients in the fezolinetant group compared to 3.5% in the placebo group.

Fezolinetant is a neurokinin 3 (NK3) receptor antagonist that blocks its action by binding to the receptor. The neurokinin 3 receptor is involved in the brain's mechanism for regulating body temperature.

Fezolinetant is not a hormone but targets the neural activity that causes menopausal hot flashes. In May 2023, the U.S. FDA approved fezolinetant for marketing to treat moderate to severe vasomotor symptoms caused by menopause. According to the press release, fezolinetant is the first NK3 receptor antagonist approved by the FDA for treating such patients.

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