FDA Advisory Committee Confirms Benefits of Leqembi to Treat Early Alzheimer Disease

In a unanimous decision, the Peripheral and Central Nervous System Drugs Advisory Committee of the Food and Drug Administration (FDA) voted to confirm the clinical benefit of Leqembi (lecanemab-irmb; Eisai, Tokyo, Japan; Biogen, Cambridge, MA) for the treatment of early Alzheimer disease (AD). Eisai reported that the Advisory Committee also discussed the use of Leqembi in specific subgroups, including apolipoprotein E (ApoE) ε4 homozygote patients, patients requiring concomitant treatment with anticoagulant agents, and patients with cerebral amyloid angiopathy. In January 2023, the FDA provided accelerated approval of the drug to treat AD, and in March 2023, the FDA granted priority review of Leqembi for traditional approval along with establishing a prescription drug user fee act (PDUFA) action date of July 6, 2023 for their decision.

The Advisory Committee reviewed results from the phase 3 Clarity AD clinical trial (NCT03887455) which evaluated the efficacy of Leqembi to treat participants with early AD.  Results from this trial revealed that individuals randomized to receive Leqembi treatment experienced less cognitive and functional decline than those who took a placebo. In addition, treatment with Leqembi was associated with improvements in secondary outcomes studied in the trial including a greater reduction in amyloid beta (Aβ) plaques visualized in PET scans and more favorable scores on other instruments including the Alzheimer’s Disease Assessment Scale and Alzheimer’s Disease Composite Score compared with those in the placebo group.

According to a statement issued by Joanne Pike, DrPH, President and CEO, Alzheimer’s Association about the decision, “We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks.”

Lecanemab is a humanized immunoglobulin gamma 1 (lgG1) monoclonal antibody directed against aggregated soluble (“protofibril”) and insoluble forms of amyloid beta (Aβ) for the treatment of those diagnosed with AD with mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology.