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August 4, 2014
09:32 EDTPTCTPTC Therapeutics announces conditional EU approval of Translarna
PTC Therapeutics announced that the European Commission has granted conditional marketing authorization for Translarna, in the European Union for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older. The authorization allows PTC to market Translarna in the 28 countries that are Member States of the European Union, as well as European Economic Area members Iceland, Liechtenstein and Norway. As part of the conditional marketing authorization, PTC is obligated to complete its confirmatory Phase 3 trial in nmDMD and submit additional efficacy and safety data from the trial.
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