Supplemental Biologics License Application Filed for Lecanemab 

Following the accelerated approval of lecanemab-irmb (Leqembi; Eisai, Tokyo, Japan; and Biogen, Cambridge MA) to treat Alzheimer Disease (AD) by the Food and Drug Administration (FDA), Eisai announced that it had filed a supplemental Biologics License Application (sBLA). This sBLA requests that the FDA convert accelerated approval for lecanemab to traditional approval. 

Data submitted for the sBLA is from the phase 3 Clarity AD clinical trial (NCT03887455), the results for which were first published in The New England Journal of Medicine. Results from this trial showed a reduction in amyloid-beta (Aβ) plaques visualized in PET scans and slower cognitive decline in those taking lecanemab compared with those taking a placebo. 

Haruo Naito, chief executive officer at Eisai comments: "The fact that Eisai was able to file LEQEMBI's supplemental Biologics License Application for traditional FDA approval on the same day we received accelerated approval demonstrates our commitment to the Alzheimer's disease community and is a major step forward in ensuring access for all those in the U.S living with this disease in need of this medicine. We will continue to actively cooperate with the FDA's review."

Lecanemab is a humanized immunoglobulin gamma 1 (lgG1) monoclonal antibody directed against aggregated soluble (“protofibril”) and insoluble forms of amyloid beta for the treatment of AD. Lecanemab is indicated as treatment for individuals diagnosed with AD with mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology. The most common adverse reactions reported were infusion-related reactions, headache, cough, and diarrhea.