G-BA indicates Translarna (ataluren) offers benefit in Duchenne Muscular Dystrophy-PTC Therapeutics
The Benefit Assessment by Germany's Federal Joint Committee (G-BA) indicated that Translarna (ataluren), from PTC Therapeutics, provided a benefit for ambulatory patients aged five years and older with nonsense mutation Duchenne Muscular Dystrophy (nmDMD).
The G-BA came to the decision that the existing clinical data package presented by PTC provided convincing evidence for the demonstration of a clinically meaningful added benefit. PTC received a 3 in the rating system established under the German pharmaceutical law. This rating is approved through June 1, 2016, at which time it will be reassessed based upon the results of PTC's global, confirmatory Phase III clinical trial in nmDMD. PTC expects top-line data from this Phase III trial in the fourth quarter of 2015.
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