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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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.
Only nine weeks after US approval, Trikafta, which in theory can treat 90% of all patients with cystic fibrosis, is already Vertex's top-selling medicine.
The European Medicines Agency has received 11 new marketing authorization applications, including three for orphan products from Vertex, MYR Pharmaceuticals and AstraZeneca.