Breaking News, Trials & Filings

Eisai, Biogen Win FDA Approval of LEQEMBI in Alzheimer’s Disease

LEQEMBI is indicated for the treatment of Alzheimer's disease in patients with mild cognitive impairment or mild dementia stage of disease.

Author Image

By: Kristin Brooks

Managing Editor, Contract Pharma

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 featur...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters