The European Medicines Agency is this week deciding whether to recommend pan-EU marketing approval for a number of new drugs, including eladocagene exuparvovec, PTC Therapeutics’ one-time gene replacement therapy for children with the rare and fatal genetic disorder, AADC deficiency. [Editor's note - PTC Therapeutics told the Pink Sheet on 26 April that eladocagene exuparvovec had been erroneously included on the April meeting agenda of the EMA's human medicines committee, the CHMP, and that it expected to receive an opinion from the CHMP in May.)
Moment Of Truth For Eight New Drugs In EU
Mix Of Novel Treatments And Generics May Get Approval Recommendation
PTC Therapeutics’ gene therapy, eladocagene exuparvovec, and Sanofi’s enzyme replacement therapy, olipudase alfa, are among the latest products that the European Medicines Agency is considering for potential marketing approval.
