US FDA approves Italfarmaco's drug for Duchenne muscle-wasting disorder
SILVER SPRING, Md., March 21, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle.
Results from Italfarmaco Pivotal Phase 3 EPIDYS Study of Givinostat in Duchenne Muscular Dystrophy (DMD) Published in The Lancet Neurology
Italfarmaco Group Receives EMA Validation of Marketing Authorization Application for Givinostat in Duchenne Muscular Dystrophy
MILAN--(BUSINESS WIRE)--Italfarmaco Group announced today that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted the company’s New Drug Application (NDA) for Givinostat. Givinostat is the company’s proprietary histone deacetylase (HDAC) inhibitor for the treatment of Duchenne Muscular Dystrophy (DMD). The compound was granted priority review by the FDA with a Prescription Drug User Fee Act (PDUFA) goal date set for December 21, 2023.