Italfarmaco Group Receives EMA’s Validation of MAA for Givinostat to Treat Duchenne Muscular Dystrophy
Shots:
- The company has submitted the MAA to the EMA for Givinostat to treat DMD & the application is currently under EMA’s review. The MAA was based on the P-III trial (EPIDYS) results of Givinostat (HDAC) inhibitor in 179 ambulant DMD patients aged ≥6yrs.
- The study met its 1EPs & evaluated functional improvement through mean change from baseline in time to climb four stairs in the target population while a variety of 2EPs were analyzed that showed results consistent with the functional 1EPs. The safety and tolerability profiles were consistent with prior study results
- The company is currently working with the regulatory authorities to bring the treatment option to patients & offer therapeutic benefits and increase their QoL
Ref: Businesswire | Image: Italfarmaco
Related News:- Sarepta Therapeutics’ Elevidys Receives the US FDA’s Accelerated Approval for the Treatment of Duchenne Muscular Dystrophy
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