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Moment Of Truth For Eight New Drugs In EU

Mix Of Novel Treatments And Generics May Get Approval Recommendation

 
• By Neena Brizmohun

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.

Red stamp and an imprint EMA (European Medicines Agency) on white surface. EMA is an agency of the EU in charge of the evaluation and supervision
Drug sponsors could soon learn whether the EMA will endorse their products • Source: Alamy

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.)

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