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Eisai Co., Ltd. and Biogen Inc. have started a rolling supplemental Biologics License Application (sBLA) with the U.S. FDA. This is for LEQEMBI® IQLIK™ (lecanemab-irmb) as a starting subcutaneous dose for patients with early Alzheimer’s disease. The FDA gave Fast Track status to this application. LEQEMBI is for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia. This is called early AD.
The submission has clinical data on subcutaneous lecanemab at different doses. This data comes from sub-studies in the Phase 3 Clarity AD open-label extension after the 18-month core trial. If approved, the LEQEMBI IQLIK 500 mg regimen would offer a new option. It uses two 250 mg autoinjectors given once a week. This would replace the current bi-weekly intravenous dosing. Patients and caregivers can pick either intravenous infusion or subcutaneous administration at home. Each autoinjector delivers the dose in about 15 seconds. This could lessen the need for infusion-related healthcare resources and make treatment easier.
Alzheimer’s disease is a progressive brain condition. It features a buildup of amyloid beta and tau. This buildup leads to ongoing neurotoxicity. LEQEMBI targets both amyloid plaque and protofibrils. Protofibrils are the most harmful form of amyloid beta. They play a key role in cognitive decline. LEQEMBI targets protofibrils to reduce neuronal damage and slow disease progression.
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LEQEMBI is approved in 48 countries. It is also under review in 10 more. Eisai manages global development and regulatory tasks for lecanemab. They also co-commercialize and co-promote the therapy with Biogen. Eisai has the final say in this partnership.
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