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

Company Needs Time To Prepare Further Data For Trikafta MAA

Executive Summary

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.

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EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.

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