German G-BA backs PTC Therapeutics' Translarna for nmDMD

22 May 2015

The benefit assessment by Germany's Federal Joint Committee (G-BA) indicated that US biotech firm PTC Therapeutics’ (Nasdaq: PTCT) Translarna (ataluren) provided a benefit for ambulatory patients aged five years and older with nonsense mutation Duchenne muscular dystrophy (nmDMD).

Translarna received conditional marketing authorization from the European Commission last year and was launched in Germany at the end of 2014 (The Pharma Letter December 3, 2014). It is still an investigational drug in the USA.

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, the company noted.

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