European Commission approves Duvyzat for the treatment of Duchenne muscular dystrophy

Italfarmaco

6 June 2025 - The approval is based on Phase 3 EPIDYS trial data that demonstrated meaningful treatment benefits in ambulant patients.

Italfarmaco announced today that the European Commission has granted conditional marketing authorisation for Duvyzat (givinostat), a novel histone deacetylase inhibitor.

Read Italfarmaco press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe , Registration