PPMD is excited to learn that the FDA completed its filing review and accepted Italfarmaco Group’s New Drug Application (NDA) for Givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor for the treatment of individuals with Duchenne. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 21, 2023 to complete its priority review and announce its decision.
Italfarmaco’s pivotal Phase 3 clinical trial EPIDYS, which included 179 ambulant boys 6 years and older, demonstrated positive results assessing the efficacy and safety of Givinostat in patients with Duchenne. Learn more about the EPIDYS trial here, and read Italfarmaco’s press release sharing topline results of the study here.
We look forward to additional updates from Italfarmaco as the review process continues, and we are so grateful to all of the families who have participated in the EPIDYS trial. We are hopeful that Givinostat will be another approved therapeutic option for the Duchenne community.
Italfarmaco will be participating in PPMD’s Annual Conference in Dallas, Texas on Friday, June 30 during the Research Row: Approved or on the Horizon sessions. Click here for more information on PPMD’s Annual Conference and registration.