EU Accelerated Assessment Tracker
Alnylam's European marketing authorization application for givosiran will be fast-tracked when the company files for approval. Only three of the nine accelerated assessment requests that the European Medicines Agency has processed this year have been successful. See our latest updates in the tracker below.
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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.
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.
KTE-X19, Kite’s potential new CAR-T therapy, will in the end be fast-tracked at the European Medicines Agency. Lilly failed to secure the speedy review it was seeking for selpercatinib