PTC: CHMP Maintains Negative Opinion On Renewal Of Conditional Marketing Authorization Of Translarna

(RTTNews) - PTC Therapeutics (PTCT) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has maintained negative opinion on the renewal of the conditional marketing authorization of Translarna for the treatment of nonsense mutation Duchenne Muscular Dystrophy following re-examination. The opinion will now be reviewed by the European Commission which is expected to decide on opinion adoption in approximately 67 days.

Matthew Klein, CEO, PTC Therapeutics, said: "As Translarna will remain authorized in Europe pending review by the European Commission, we will continue to ensure Translarna is available to boys and young men living with nonsense mutation Duchenne muscular dystrophy. In addition, PTC will ensure the EC has all possible evidence to support continued authorization."

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