PTC Therapeutics To Begin Shipments Of Translarna In Germany - Quick Facts

(RTTNews) - PTC Therapeutics Inc. (PTCT) announced that Translarna is now commercially available to patients in Germany, with first shipments expected to begin current week. The launch follows the European Commission marketing authorization, which was received in August 2014 for the use of Translarna to treat ambulatory patients with nonsense mutation Duchenne muscular dystrophy who are 5 years and older. Currently, Translarna is not approved for use in the United States.

The company noted that a confirmatory Phase 3 clinical trial of Translarna, ACT DMD, in nonsense mutation Duchenne muscular dystrophy patients completed enrollment in September 2014. Top-line data is expected in the fourth quarter of 2015.