Eisai/Biogen’s Lecanemab Effective Across Endpoints, But Will Safety Limit Use?
CTAD Presentation Is First Detailed Data
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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The biggest barrier for Eisai/Biogen’s Alzheimer’s medicine Leqembi was Medicare. With full US FDA approval and Medicare coverage in place, PET scan, MRI and infusion centers are needed to facilitate treatment.
CMS will cover Leqembi now that the US FDA has converted Leqembi’s accelerated approval to traditional approval, giving most patients eligible for treatment access to the drug. Updated labeling puts greater emphasis on safety concerns.
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.