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Lecanemab Conversion From Accelerated To Full Approval Could Be Among Fastest Ever

 
• By Bridget Silverman

Biogen/Eisai’s Phase III data is on track for a Q1 2023 submission, potentially just weeks after lecanemab is expected to gain accelerated approval for early Alzheimer’s.

brain over the finish line
Lecanemab could be one of the fastest accelerated approvals to cross the full approval finish line. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

Biogen, Inc. and Eisai Co., Ltd. plan to submit an application for regular approval of lecanemab in early Alzheimer’s disease by the end of March 2023 based on the confirmatory Phase III CLARITY trial, shortly after the anti-amyloid beta protofibril antibody’s 6 January 2023 user fee goal date for accelerated approval.

The US FDA typically advises sponsors seeking accelerated approval to start their confirmatory studies as early as possible, but it...

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