Astellas Pharma shares positive results from phase 3b trial of Fezolinetant for menopause symptoms
Astellas Pharma has announced positive topline results from the phase 3b DAYLIGHT clinical trial for fezolinetant, its investigational oral, nonhormonal compound being studied for treating moderate to severe vasomotor symptoms (VMS) due to menopause.
VMS includes hot flashes and night sweats, both of which are common symptoms of menopause. The study included over 450 women who were considered unsuitable for hormone therapy, and met its primary objective of statistically significant reduction in the frequency of moderate to severe VMS to week 24 with treatment with fezolinetant 45mg once daily, compared to placebo. Less than 5% of patients experience treatment emergent adverse events (TEAE).
Fezolinetant was approved by the US Food and Drug Administration (FDA) in May 2023, and the company is now seeking regulatory approval elsewhere, including in Europe. The DAYLIGHT study has provided additional safety and efficacy data to be used in these applications.
Marci English, vice president and head of BioPharma Development at Astellas, commented: “We are delighted 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.”
Astellas Pharma has announced that it is preparing to submit a planning application to build …
Clinical stage biopharmaceutical company Nuvectis Pharma has announced the initiation of a phase 1a dose …