EMA validates application for givinostat in DMD

5 September 2023

Italy’s privately-held drug developer Italfarmaco Group today revealed that its Marketing Authorization Application (MAA) for Givinostat as a potential treatment for Duchenne muscular dystrophy (DMD) has been submitted to the European Medicine Agency (EMA) and that the EMA has started its regulatory review process.

The MAA submission was based on the safety and efficacy results from the Phase 3 EPIDYS clinical trial which tested givinostat, a histone deacetylase (HDAC) inhibitor, in patients with DMD.

This submission comes just two months after the US Food and Drug Administration (FDA) granted priority review for givinostat. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date set for December 21, 2023.

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