Update on Duvyzat™ (givinostat) for Duchenne Muscular Dystrophy

We want to share an important update that may be relevant to families living with Duchenne muscular dystrophy (DMD).

Duvyzat™ (givinostat) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for conditional approval. This recommendation applies to boys who are 6 years and older who are still able to walk and are currently taking corticosteroids as part of their treatment.

The CHMP’s recommendation has now been passed to the European Commission (EC), which will make the final decision. A response is expected by July, as the EC typically issues a decision within approximately 67 days of receiving the CHMP’s opinion.

We understand how important timely updates are for families, and we’ll continue to share new information as it becomes available.

If you’d like to read the official press release from the European Medicines Agency (EMA), you can find it here:
🔗 EMA Press Release 

To learn more about how medicines are approved in the European Union, click here:
🔗 Understanding EU Drug Approval