Published on 27 Jan 2023 on Zacks via Yahoo Finance

Biogen (BIIB) & Eisai's Lecanemab Secures EMA's MAA Acceptance

Biogen Inc. BIIB and Japanese partner Eisai,announced that the European Medicine Agency (EMA) accepted its marketing authorization application (MAA) for standard review for lecanemab to treat early-stage Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease [AD] and mild AD dementia), having confirmed amyloid pathology.

Earlier this January, lecanemab was granted accelerated approval in the United States for the treatment of AD by the FDA. The drug will be marketed under the brand name Leqembi. Its label mentions that treatment with the drug should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical studies. Based on data from this study, Eisai also filed a supplemental biologics license application (sBLA) to the FDA to get traditional approval for Leqembi. This sBLA submission wasbased on data from the phase III Clarity AD confirmatory study.

Lecanemab is a monoclonal antibody that selectively binds and eliminates amyloid-beta (Aβ) protofibrils which cause neurotoxicity in AD. The accelerated approval was based on data from a phase II study (Study 201), which showed that treatment with lecanemab reduced the accumulation of Aβ plaque in the brain.