Shots:
- The EC has granted conditional approval to Duvyzat (givinostat) for the treatment of ambulant DMD pts (≥6yrs.) on corticosteroids, regardless of underlying genetic mutation in all 30 EEA states
- Approval was based on the P-III (EPIDYS) study assessing Duvyzat (BID) vs PBO in ambulant DMD boys (n=179) on corticosteroid therapy
- Trial met its 1EP by improving four-stair climb completion time, with benefits seen in 2EPs (NSAA & MRI fat infiltration) & a 40% decrease in cumulative NSAA item loss; data was published in The Lancet Neurology. Ongoing extension trial data showed delay in DMD progression, with median ambulation loss at 18.1 vs 15.2yrs. for controls
Ref: GlobeNewswire | Image: Italfarmaco| Press Release
Related News:- Italfarmaco Obtains the CHMP’s Positive Opinion for Conditional Marketing of Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)
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