PTC Receives Positive Opinion From CHMP For Translarna - Quick Facts

(RTTNews) - PTC Therapeutics Inc. (PTCT) announced that following its request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the company's application for a conditional marketing authorization of Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older.

The CHMP opinion will form the basis for a European Commission decision as to whether to formally grant the conditional marketing authorization. The European Commission will review the positive opinion from the CHMP and generally delivers its final decision within three months.

The company said the conditional marketing authorization would authorize it to market Translarna with unified labeling in the 28 countries that are Member States of the European Union, as well as European Economic Area members Iceland, Liechtenstein and Norway.