Regulatory roadblock for rival Alzheimer's disease treatment

20 January 2023

Patient groups have expressed disappointment that USA-based drugmaker Eli Lilly (NYSE: LLY) has not been granted an Accelerated Approval for its Alzheimer’s disease candidate, donanemab.

Lilly’s option is an amyloid-clearing antibody, much like Eisai (TYO: 4523) and Biogen’s (Nasdaq: BIIB) Leqembi (lecanemab), which was granted a speedy nod in the USA last year.

However, the US Food and Drug Administration has issued a Complete Response Letter (CRL) for Lilly’s submission, which has now collected more encouraging data in the TRAILBLAZER-ALZ 4 trial.

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