PTC Therapeutics Loses EU Authorization for Translarna in Duchenne Muscular Dystrophy

MT Newswires Live
28 Mar

PTC Therapeutics (PTCT) said Friday that the European Commission has adopted the recommendation of the Committee for Medicinal Products for Human Use to not renew Translarna's marketing authorization for nonsense mutation Duchenne muscular dystrophy.

The commission indicated that under EU Directive 2001/83, individual member states in the European Union can still allow continued use of Translarna, the company said.

PTC Therapeutics said it plans to work on a country-by-country basis to continue marketing

Translarna, or ataluren, for Duchenne muscular dystrophy in the region.

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