Italfarmaco Obtains the EC’s Conditional Approval for Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

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…

ByRidhi RastogiJune 9, 2025

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…

ByRidhi RastogiApril 28, 2025

Italfarmaco’s Duvyzat Obtains the US FDA’s Approval to Treat Duchenne Muscular Dystrophy

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…

ByDipanshu DixitMarch 22, 2024

Italfarmaco Obtains the EC’s Conditional Approval for Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Italfarmaco Obtains the CHMP’s Positive Opinion for Conditional Marketing of Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Italfarmaco’s Duvyzat Obtains the US FDA’s Approval to Treat Duchenne Muscular Dystrophy

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Italfarmaco Obtains the EC’s Conditional Approval for Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Italfarmaco Obtains the CHMP’s Positive Opinion for Conditional Marketing of Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Italfarmaco’s Duvyzat Obtains the US FDA’s Approval to Treat Duchenne Muscular Dystrophy

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