EC approves Duvyzat for the treatment of DMD

Privately-held Italian pharma company Italfarmaco today revealed that the European Commission (EC) has granted conditional marketing authorization for Duvyzat (givinostat), a novel histone deacetylase (HDAC) inhibitor.

The drug is approved for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients six years and older, regardless of the underlying genetic mutation, when taken together with corticosteroids.

The EC decision follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on April 25, 2025. The approval applies to all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. Italfarmaco is now working closely with national authorities and distribution partners to facilitate timely access to Duvyzat across the European Union (EU).