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European Commission Dangles Conditional Approval Reprieve For PTC Therapeutics’ Translarna

 
• By Francesca Bruce

Scientific questions from member state experts and a recent court ruling on impartiality in the drug approval process prompted the European Commission to query the EMA’s negative opinion on PTC’s Translarna.

Bright horizon
A Brighter future for PTC's Translarna is possible after the European Commission has returned CHMP negative opinion • Source: Shutterstock

In a very rare move, the European Commission has rejected advice from the European Medicines Agency not to renew the conditional marketing authorization (CMA) for PTC Therapeutics’ rare disease treatment Translarna (ataluren), the first ever treatment approved for Duchenne muscular dystrophy.

The commission has asked the EMA to review its scientific assessment of the drug following scientific questions from EU member...

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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

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