The European Commission (EC) has given conditional marketing authorization to the new histone deacetylase (HDAC) inhibitor Duvyzat (givinostat), Italfarmaco announced on 6th June. When used in conjunction with corticosteroids, it is authorized to treat Duchenne muscular dystrophy (DMD) in ambulatory patients aged 6 and up, irrespective of the underlying genetic mutation. (What is Duvyzat (Givinostat))
The EC decision comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a favorable opinion on April 25, 2025 (Read More: EMA Recommends EU Approval for Duvyzat). All 27 EU members as well as Iceland, Liechtenstein, and Norway are covered by the approval. In order to provide prompt access to Duvyzat throughout the EU, Italfarmaco is now collaborating closely with national authorities and distribution partners.
Learn More: Givinostat’s Exclusive Distribution Agreement in 17 Central and Eastern European Countries
Is Givinostat (Duvyzat) Approved by EMA?
- Now approved in the EU, Duvyzat offers an important treatment option for delaying Duchenne muscular dystrophy (DMD) disease progression
- Duvyzat is an orally administered treatment for DMD in patients 6 years and older who are able to walk
- The approval is based on Phase 3 EPIDYS trial data that demonstrated meaningful treatment benefits in ambulant patients
Duvyzat has been given conditional marketing authorization by the European Commission in the EU. As Italfarmaco carries out more clinical research aimed at further confirming and characterizing its therapeutic efficacy, the approval opens up Duvyzat to ambulant DMD patients aged 6 and up.
In March 2024, the US Food and Drug Administration (FDA) approved Duvyzat for use in treating DMD patients aged 6 and up outside of the EU. In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) approved Duvyzat for ambulatory patients aged 6 and up and conditionally approved it for non-ambulatory patients.
