Astellas’ Fezolinetant Reduces Frequency and Severity of VMS Associated with Menopause in Women Considered Unsuitable for Hormone Therapy
Astellas Pharma Inc. (TSE: 4503) is set to present 24-week results from the Phase 3b DAYLIGHT clinical trial at the 15th Congress of the European Society of Gynecology in Amsterdam, The Netherlands. The trial assessed the efficacy and safety of fezolinetant, an oral, nonhormonal compound, in treating moderate to severe vasomotor symptoms (VMS) associated with menopause in women considered unsuitable for hormone therapy.
Key findings from the study, which included over 450 women unsuitable for hormone therapy, revealed that fezolinetant 45 mg demonstrated statistically significant reductions compared to placebo in the frequency and severity of moderate to severe VMS. The primary endpoint, mean change from baseline in VMS frequency, showed a reduction of -1.93 (p<0.001) for fezolinetant 45 mg compared to placebo. Additionally, the secondary endpoint for VMS severity demonstrated a reduction of -0.39 (p<0.001), and the mean change in patient-reported sleep disturbance showed a reduction of -2.5 (p<0.001) for fezolinetant 45 mg compared to placebo.
The study reported treatment-emergent adverse events (TEAEs) in 65% of patients in the fezolinetant group and 61% in the placebo group. The most common TEAEs included COVID-19, headache, and fatigue. Serious TEAEs occurred in 4.4% of the fezolinetant group and 3.5% of the placebo group.
Prof. Rossella Nappi, Chief of the Research Center for Reproductive Medicine, expressed optimism about the results, highlighting the potential of fezolinetant to provide options for managing VMS in menopausal women unsuitable for hormone therapy. Marci English, Head of BioPharma Development at Astellas, emphasized the study’s significance as the first 24-week placebo-controlled efficacy trial for fezolinetant.
DAYLIGHT, a Phase 3b study, enrolled 453 menopausal women aged 40-65, considering unsuitability for hormone therapy. The trial’s primary endpoint was the mean change in VMS frequency, with secondary endpoints focusing on VMS severity and patient-reported sleep disturbance.
Fezolinetant is an investigational oral, nonhormonal medicine designed to address moderate to severe VMS associated with menopause by blocking neurokinin B binding on the KNDy neuron. Astellas, a global pharmaceutical company, is committed to advancing innovative science and creating healthcare solutions.
While these results are promising, it’s important to note that regulatory approval in Europe and commercial availability are not guaranteed. Astellas encourages healthcare providers with the positive impact of fezolinetant on VMS over an extended period.
Cautionary Notes: The press release includes forward-looking statements about Astellas’ future performance, based on current assumptions and beliefs. These statements involve known and unknown risks and uncertainties that could cause actual results to differ materially. Factors include economic conditions, regulatory changes, currency exchange fluctuations, product launches, marketing effectiveness, and intellectual property rights infringements.
