BioArctic’s partner Eisai has announced that under the Accelerated Approval pathway the U.S. Food and Drug Administration (FDA) has approved lecanemab-irmb (Brand Name in the U.S.: LEQEMBI) for the treatment of Alzheimer’s disease.
The approval concerns lecanemab-irmb (Brand Name in the U.S.: LEQEMBI) 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (“protofibrils”) and insoluble forms of amyloid beta (Aβ) for the treatment of Alzheimer’s disease (AD), describes BioArctic in a press release.
“The FDA’s approval of LEQEMBI under the Accelerated Approval pathway is an important milestone not only for BioArctic and our partner Eisai, but for the whole field as well as for patients, families and caregivers who can now benefit from the more than 20 years of research and development that lies behind this achievement. We are impressed by our partner Eisai’s excellent work with LEQEMBI and are proud of our long-standing relationship that has led us to today’s announcement,” says Gunilla Osswald, CEO at BioArctic.
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Based on Phase 2b data
The accelerated approval is based on Phase 2b data in early AD patients which demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD.
“The approval of lecanemab-irmb by the FDA entitles BioArctic to a milestone payment of MEUR 25 from Eisai.”
Using the recently published data from the large global confirmatory Phase 3 clinical trial, Clarity AD, Eisai will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. The approval of lecanemab-irmb by the FDA entitles BioArctic to a milestone payment of MEUR 25 from Eisai.