Translarna filed on rolling submission with FDA for nmDMD-PTC Therapeutics

PTC Therapeutics has announced that it has commenced a rolling submission of a New Drug Application (NDA) to the FDA for Translarna (ataluren) for the treatment of nonsense mutation Duchenne Muscular Dystrophy (nmDMD). A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis. PTC expects to finalize the application in the fourth quarter of 2015 following the completion of the ACT DMD confirmatory Phase III clinical trial. Translarna was approved for DMD in May 2014.