The Ups And Downs Of Aducanumab’s Rollercoaster Development Program
The Biogen Alzheimer’s product saw its ‘likelihood of approval’ score from Biomedtracker change directions multiple times as it moved through clinical trials and US FDA review.
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Novel agents that received three-month user fee goal date extensions have a slightly higher approval rate than novel applications overall.
Agency anticipated receiving more applications for the program, which aims to bring Operation Warp Speed-like response to investigational rare disease therapies, than it has so far, though a last-minute ‘flood’ is still expected. CBER and CDER are accepting requests through 1 March.
Offering a regulatory Mt. Rushmore to place the outgoing principal deputy commissioner in historical context.