Astellas Pharma shares positive results from phase 3b trial of Fezolinetant for menopause symptoms
Betsy Goodfellow | June 28, 2023 | News story | Medical Communications | Astellas Pharma, Pharmacy, clinical trial, fezolinetant, menopause
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.”
Betsy Goodfellow
Related Content
The Pharma Files: With Colin Williams from Astellas Pharma
Pharmafile chats with Colin Williams, Head of Marketing Excellence, Global Capabilities, Learning & Development at …
UCB announces first-in-patient trial success for galvokimig in atopic dermatitis
UCB has reported positive early clinical trial results for galvokimig, an investigational therapy for adults …
FDA approves Wegovy for treatment of MASH in adults with liver fibrosis
The US Food and Drug Administration (FDA) has granted accelerated approval for Wegovy (semaglutide) as …
