Shots:
- The US FDA has granted approval to Italfarmaco’s Duvyzat (givinostat), histone deacetylase (HDAC) inhibitor, to treat Duchenne muscular dystrophy (DMD) patients (6yrs. or above)
- The approval was supported by the P-III (EPIDYS) study assessing the safety & efficacy of Duvyzat (BID) vs PBO in DMD ambulant male patients (n=179, 6yrs. or above)
- The trial met the 1EP showing a meaningful difference in time to complete the four-stair climb evaluation. Favorable outcomes were also observed across 2EPs such as NSAA & fat infiltration assessment through MRI. The findings were published in The Lancet Neurology
Ref: PRNnewswire | Image: Italfarmaco | Press Release
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