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EU Fast-Track Loss For Vertex’s CF Triple Combo

Company Needs Time To Prepare Further Data For Trikafta MAA

 
• By Maureen Kenny

Vertex is hoping for EU approval in Q4 of its cystic fibrosis triple combination therapy, Trikafta. It wants the same licence in the EU as it has in the US, where the product has already become a best seller for the company.

Cystic_Fibrosis
EU review of new CF combination therapy is under way • Source: Shutterstock

The EU marketing authorization application (MAA) for Vertex Pharmaceuticals' cystic fibrosis triple combination regimen of elexacaftor/tezacaftor/ivacaftor has lost its accelerated assessment status and is now being reviewed under standard review timelines at the European Medicines Agency.

Vertex said it had received questions from the EMA that would only be possible to answer with further data...

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