Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS
Astellas to Air New VEOZAH® (fezolinetant) TV Spot During the Super Bowl
Astellas' VEOZA Approved by EC for Treatment of Vasomotor Symptoms
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) this week recommended seven new drugs for authorization, including Pfizer’s potential multiple myeloma blockbuster elranatamab and Astellas’ hot flash treatment fezolinetant.
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.
SILVER SPRING, Md., May 12, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain's regulation of body temperature.
Astellas’ bid to bring menopause drug candidate fezolinetant to market has hit a last-minute snag. Just days before the approval decision date, the FDA has extended the review by three months to give it more time to complete its assessment.