Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China – QNT Press Release


Clinical trial evaluated the safety and tolerability of 30 mg dose for the treatment of vasomotor symptoms (VMS) associated with menopause

TOKYO, Sept. 4, 2022 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji YasukawaPh.D., “Astellas”) today announced topline results from the Phase 3 MOONLIGHT 3™ clinical trial in women in mainland China evaluating the long-term safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2

MOONLIGHT 3 is a 52-week single-arm Phase 3 clinical trial investigating the long-term safety and tolerability of fezolinetant 30 mg taken once daily in 150 women in mainland China seeking treatment for relief of VMS associated with menopause. The study’s primary endpoint is the frequency and severity of adverse events (AEs), which were generally consistent with previous Phase 3 studies of fezolinetant. Detailed results will be submitted for publication in the near future.

“The topline results from the MOONLIGHT 3 study are very encouraging and, upon initial review, further support the long-term safety of fezolinetant,” said Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Development Therapeutic Areas, Astellas. ” We are evaluating the full MOONLIGHT data sets and remain committed to developing innovative treatments in this therapeutic area with the hope of delivering a first-in-class, nonhormonal treatment option for women with moderate to severe VMS.”

Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist and is not approved anywhere in the world. In the US, a New Drug Application for fezolinetant for the treatment of moderate to severe VMS associated with menopause is under review. The NDA . ..

Full story available on Benzinga.com



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