Italfarmaco Group Announces New PDUFA Date for Givinostat DMD NDA
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.
MILAN--(BUSINESS WIRE)--Italfarmaco Group announced today positive topline data from its completed Phase 3 EPIDYS trial with Givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor, in boys with Duchenne Muscular Dystrophy (DMD). The primary objective of the study was to evaluate the effects of Givinostat on slowing disease progression in ambulant DMD boys aged 6 years and above on chronic steroids. The study compared Givinostat to placebo and met the primary endpoint (change from baseline in the time to climb 4 stairs) following 18 months of treatment in the target population1 with key secondary endpoints consistent with the functional primary endpoint. Givinostat continued to demonstrate a tolerability profile in line with previous studies. The topline data were presented by Italfarmaco Group’s Chief Medical Officer, Dr. Paolo Bettica on June 25, 2022, at the hybrid Parent Project Muscular Dystrophy (PPMD) Annual Conference.