Lilly’s Donanemab Slows Cognitive Decline; FDA Filing Imminent

Full Approval Sought After Accelerated Nod Denied Previously

 
• By Mandy Jackson
  
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The company’s anti-amyloid antibody succeeded in Phase III with efficacy at least on par with Eisai/Biogen’s Leqembi, but with ARIA-related deaths unseen with the rival therapy.

Alzheimer's disease on MRI
Donanemab slowed cognitive decline in Phase III • Source: Shutterstock

Eli Lilly and Company remains months behind Eisai Co., Ltd./Biogen, Inc. in bringing an anti-amyloid antibody to market, but with Phase III TRAILBLAZER-ALZ 2 trial results on 3 May showing a 35% slowing in clinical decline for early Alzheimer’s patients treated with donanemab, Lilly plans to file for US Food and Drug Administration during the second quarter of 2023. The data appear to show greater efficacy than seen with Eisai/Biogen’s Leqembi (lecanemab) last year, although with greater risks.

Lilly said it intends to work with the FDA and other regulators “to achieve the fastest path to traditional approvals.”...

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