Eisai Co., Ltd. and Biogen Inc. received approval for lecanemab-irmb (LEQEMBI) 100 mg/mL injection, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (“protofibril”) and insoluble forms of amyloid beta (Abata) for the treatment of Alzheimer’s disease (AD) under the Accelerated Approval Pathway. The approval is based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD. Using data from the global confirmatory Phase 3 clinical trial, Clarity AD, Eisai will work to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.
 
LEQEMBI is indicated for the treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with LEQEMBI. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
 
The safety of LEQEMBI has been evaluated in 763 patients who received at least one dose of LEQEMBI in Study 201. The most common adverse reactions reported in at least 5% of patients treated with LEQEMBI and at least 2% higher incidence than patients on placebo were infusion-related reactions (LEQEMBI 20%; placebo 3%), headache (LEQEMBI 14%; placebo 10%), ARIA-E (LEQEMBI 10%; placebo 1%), cough (LEQEMBI, 9%; placebo, 5%) and diarrhea (LEQEMBI, 8%; placebo, 5%). The most common adverse reaction leading to discontinuation of LEQEMBI was infusion- related reactions that led to discontinuation in 2% (4/161) of patients treated with LEQEMBI compared to 1% (2/245) of patients on placebo.
 
“The FDA’s approval of LEQEMBI under the Accelerated Approval pathway is an important milestone in Eisai’s four decades of research in Alzheimer’s disease and reflects our continued commitment to alleviating the burden of Alzheimer’s disease for patients and their families. Eisai has made great efforts to understand the reality of the challenges and concerns facing patients and their families who are living in the various stages of Alzheimer’s disease, and we are incredibly pleased to offer LEQEMBI as a new treatment option to help with the tremendous unmet needs of this community,” said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. “Upon receiving this Accelerated Approval, we will focus on providing important information on proper usage of LEQEMBI to healthcare professionals. Eisai will also engage with various payers to provide access to LEQEMBI, offer a patient support program, and will do its utmost to complete submission for traditional approval as soon as possible to serve more people living with early Alzheimer’s disease.”
 
“The approval of LEQEMBI provides new hope to patients with Alzheimer’s disease. Patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors. Our focus now is on the path forward, working alongside Eisai with the goal of making LEQEMBI available to patients who may benefit from this treatment as soon as possible,” said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen. “This approval is also a recognition of the many scientists and doctors who have, over many years, patiently and persistently worked to find a treatment for this highly complex disease. Eisai and Biogen have collaborated for nearly a decade to advance research to improve the lives of those suffering from Alzheimer’s, and we know that this commitment must and will continue in the fight against Alzheimer’s disease.”