Italfarmaco Obtains the CHMP’s Positive Opinion for Conditional Marketing of Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)
Shots:
- Opinion for Duvyzat to treat ambulant DMD pts (≥6yrs.) with corticosteroids is based on P-III (EPIDYS) study assessing Duvyzat (BID) vs PBO in ambulant boys (n=179); EC’s decision expected in Jul 2025
- 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; data presented at MDA conference
- Duvyzat is being evaluated in 2 trials: P-III to determine its safety & efficacy in non-ambulant DMD pts (≥9yrs.) & P-II to assess safety + early treatment benefits in DMD pts (2-5yrs.)
Ref: GlobeNewswire | Image: Italfarmaco
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
