EU Fast-Track Loss For Vertex’s CF Triple Combo
Company Needs Time To Prepare Further Data For Trikafta MAA
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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The European public assessment report for Kaftrio shows that EU regulators had concerns about whether Vertex’s triple drug combination for cystic fibrosis represented a new treatment paradigm.
A number of companies with marketing applications at the later stages of the EU review process are seeking extra time to address remaining concerns the European Medicines Agency’s drug evaluation committee, the CHMP, has about their filings.
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.