PTC Therapeutics, Inc. (PTCT) announced that the European Commission has adopted the opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency to not renew the authorization of Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy. This action effectively removes the drug's conditional marketing authorization in the European Economic Area.
Matthew Klein, CEO, PTC Therapeutics, said: "The EC's indication that European Union member states have a mechanism to maintain treatment speaks to the safety, benefit and lack of alternative therapies for boys and young men with nonsense mutation Duchenne muscular dystrophy. We look forward to working on a country-by-country basis to provide commercial drug where possible."
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