PTCT - European Commission Requests Reevaluation Of Opinion On PTC Therapeutics' Duchenne Dystrophy Drug; Pauses Annual Guidance | Benzinga
Monday, PTC Therapeutics Inc (NASDAQ:PTCT) announced that the European Commission (EC) has decided not to adopt the CHMP’s negative opinion on the annual renewal of the conditional marketing authorization of Translarna (ataluren) and has returned the opinion to the CHMP for re-evaluation.
As a result, Translarna remains on the market and available for patients in Europe, consistent with its current marketing authorization.
The EC has asked the CHMP to further consider the totality of evidence, including data from patient registries and real-world evidence, in a revised opinion.
In addition, the European Medicines Agency ...