Italfarmaco Group announced an extension in the FDA’s review of the New Drug Application (NDA) for Givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor for the potential treatment of Duchenne. The new Prescription Drug User Fee Act (PDUFA) date, which is the deadline set by the FDA for their decision about whether to approve an investigational product, is March 21, 2024.
Italfarmaco shared that the FDA extended the PDUFA date to allow additional time to review information submitted by Italfarmaco as part of the NDA process.
While we are disappointed in the delay, we are hopeful this additional time will contribute to a thorough review and that the FDA will exercise regulatory flexibility as they weigh the benefits and risks of Givinostat. We appreciate Italfarmaco’s commitment to collaboration with the FDA throughout this process.