Italfarmaco completes givinostat NDA with FDA

Italy’s privately-held Italfarmaco Group has taken another pivotal step towards approval of its proprietary histone deacetylase (HDAC), givinostat, in Duchenne muscular dystrophy (DMD).

Today the company announced the completion of its New Drug Application (NDA) with the US Food and Drug Administration (FDA), as a result of which Italfarmaco will receive priority review with a Prescription Drug User Fee Act (PDUFA) goal date set for December 21, 2023.

The NDA submission is grounded in Italfarmaco’s completed clinical development program which demonstrated positive results assessing the efficacy and safety of givinostat in patients with DMD.