CHMP Recommends EU Approval for Duvyzat to Treat Duchenne Muscular Dystrophy

Italfarmaco S.p.A. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a conditional marketing authorization for Duvyzat^®, a novel histone deacetylase inhibitor. The authorization is for the treatment of patients with Duchenne muscular dystrophy aged six years and older who are able to walk, when taken together with corticosteroids.