On the 25th of April, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave givinostat (Duvyzat), a novel histone deacetylase (HDAC) inhibitor, a positive opinion. The recommendation is for granting a conditional marketing authorisation for givinostat for the treatment of ambulant patients with Duchenne Muscular Dystrophy (DMD) aged six years, and alongside concomitant corticosteroid treatment in the European Union (EU).
This positive recommendation needs to be reviewed by the European Commission (EC) within 67 days before the treatment is made available in the EU. The European Commission will review the CHMP’s recommendation and is expected to make a final decision in July 2025.
More information: https://www.ema.europa.eu/en/news/new-treatment-against-duchenne-muscular-dystrophy