FDA Advisory Committee votes unanimously to confirm the clinical benefit of Leqembi for the treatment of Alzheimer’s disease.- Eisai + Biogen

Additionally, the committee members confirmed the overall benefit-risk profile of Leqembi, the clinical meaningfulness of the data and discussed its use in specific subgroups, including Apolipoprotein E (ApoE) e4 homozygote patients, patients requiring concomitant treatment with anticoagulant agents, and patients with cerebral amyloid angiopathy.

The unanimous decision by the panel of independent experts was based on the supplementary Biologics License Application (sBLA) which includes data from Eisai’s large global confirmatory Phase III Clarity AD trial. The Clarity AD trial met its prespecified primary endpoint, demonstrating a highly statistically significant slowing of cognitive and functional decline (27%, p=0.00005) compared to placebo over 18 months. Highly statistically significant treatment effects were also observed for all multiplicity-controlled secondary endpoints that examined cognition and functional changes using other validated scales.

The most common adverse events ( greater than 10%) in the Leqembi group were infusion reactions (Leqembi; 26.4%; placebo: 7.4%), ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis: Leqembi: 17.3%; placebo: 9.0%), ARIA-E (edema/effusion: Leqembi 12.6%; placebo: 1.7%), headache (Leqembi: 11.1%; placebo: 8.1%), and fall (Leqembi: 10.4%; placebo: 9.6%). Infusion reactions were largely mild-to-moderate (grade 1-2: 96%) and occurred on the first dose (75%).

The results of the Clarity AD study were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine [nejm.org]. (previously cited).