Posted by Michael Wonder on 06 Sep 2023
Italfarmaco Group receives EMA validation of marketing authorisation application for givinostat in Duchenne muscular dystrophy
5 September 2023 - Italfarmaco Group announced today that its marketing authorisation application for givinostat as a potential treatment for Duchenne muscular dystrophy has been submitted to the EMA and that the EMA has started its regulatory review process.
The submission was based on the safety and efficacy results from the Phase 3 EPIDYS clinical trial which tested givinostat, a histone deacetylase inhibitor, in patients with Duchenne muscular dystrophy.
