Acadia Pharmaceuticals announces FDA approval of DAYBUE for Rett syndrome

Acadia Pharmaceuticals announced that the U.S. Food and Drug Administration has approved DAYBUE for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. DAYBUE is the first and only drug approved for the treatment of Rett syndrome. The FDA approval of DAYBUE was supported by results from the pivotal Phase 3 LAVENDER study evaluating the efficacy and safety of trofinetide versus placebo in 187 female patients with Rett syndrome five to 20 years of age. DAYBUE is expected to be available in the U.S. by the end of April, 2023. With the FDA approval of DAYBUE, Acadia has received a Rare Pediatric Disease Priority Review Voucher, which can be used to obtain priority review for a subsequent application.