Eisai/Biogen Maintain Lead Over Lilly In New Race To Alzheimer’s Approval
Full Approval Filing May Quickly Follow Accelerated US FDA Decision
The US FDA accepted an application for accelerated approval and set a 6 January action date, giving lecanemab ample time to reach the market ahead of Lilly’s competing anti-amyloid antibody donanemab.
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Phase III results for Eisai/Biogen’s lecanemab are the main event at the Clinical Trials on Alzheimer’s Disease meeting, but other data – even Roche’s failed Phase III gantenerumab studies – also may have implications for the amyloid-clearing antibody.
Eisai and Biogen had double-digit stock price gains based on the positive Phase III readout for lecanemab. The good news also lifted competitors Lilly and Roche as well as earlier-stage Alzheimer’s drug developers.
After the Aduhelm controversy, Eisai/Biogen, Roche and Lilly are lining up Phase III results for their candidates which, against the odds, they hope could finally represent real progress in Alzheimer’s treatment. Scrip takes a look at the key questions surrounding the field as the drugs await their fate.