Source – Astellas Pharma
Astellas Pharma recently announced positive preliminary findings on June 27, 2023, from the Phase IIIb DAYLIGHT (NCT05033886) clinical trial evaluating fezolinetant, an oral nonhormonal compound, as a potential treatment for moderate to severe vasomotor symptoms (VMS) caused by menopause. VMS, which includes hot flashes and night sweats, are commonly experienced during menopause.
“We are delighted that the initial assessment of the DAYLIGHT study further validates the role of fezolinetant in reducing the frequency of moderate to severe VMS due to menopause. These 24-week placebo-controlled data add to our growing base of clinical evidence established in the SKYLIGHT studies and provide additional insights on the safety and effectiveness of fezolinetant in women who cannot or choose not to take hormone therapy.”
– Marci English, Vice President, Head of BioPharma Development, Astellas
The study involved over 450 women who were deemed unsuitable for hormone therapy. The primary objective of the trial was to assess the reduction in the frequency of moderate to severe VMS from baseline to week 24 when treated with a daily dose of fezolinetant 45 mg compared to a placebo. The results showed a statistically significant decrease in VMS frequency for the fezolinetant group. Serious treatment-emergent adverse events (TEAE) were observed in less than 5% of patients, with the most common TEAEs being COVID-19 and headaches. Detailed results from the study will be submitted for publication and consideration at an upcoming medical conference.
Fezolinetant, known as Veozah, received approval from the US Food and Drug Administration (FDA) in May 2023. Astellas Pharma is now seeking regulatory approval for fezolinetant in various other countries and regions, including Europe. The DAYLIGHT trial’s additional efficacy and safety data will primarily support the health technology assessment (HTA) and reimbursement dossiers for fezolinetant in Europe.
