PTC Therapeutics (NASDAQ: PTCT) announced that the European Commission (EC) has adopted the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) opinion to not renew the authorization of Translarna™ (ataluren) for treating nonsense mutation Duchenne muscular dystrophy.
This decision effectively removes the drug's conditional marketing authorization in the European Economic Area. However, the EC indicated that individual EU countries can use Articles 117(3) and 5(1) of the EU Directive 2001/83 to allow continued Translarna use. PTC Therapeutics plans to work on a country-by-country basis to provide commercial drug where possible.
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