Innovative drug approval pathways are the order of the day
This article was originally published in SRA
In the US, the Food and Drug Administration has granted its first "breakthrough therapy" designations – for two experimental cystic fibrosis treatments – under a new programme designed to expedite the development and review processes for medicines intended to treat serious or life-threatening diseases. The scheme joins an already busy mix of expedited drug development and review programmes in the US – fast track, priority review and accelerated approval.
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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