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Eisai/Biogen’s Lecanemab Effective Across Endpoints, But Will Safety Limit Use?

CTAD Presentation Is First Detailed Data

Executive Summary

Alzheimer’s patients treated with the amyloid protofibril-clearing antibody had slower disease progression compared to placebo, with differences increasing over time. Safety concerns, however, are growing. 

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US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s

Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.

US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s

More long-term data for donanemab needed, FDA says. Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.

Eisai’s Lecanemab: US FDA Showed Flexibility On Clinical Endpoint Results, Safety Database Size

Alzheimer’s drug’s failure to meet Phase II endpoint did not preclude accelerated approval in light of statistically significant reduction in amyloid plaque and ‘generally consistent and favorable results on clinical endpoints.’ Size of six-month safety database also fell shy of ICH guidelines.

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