Health
Rolling sBLA initiated to the U.S. FDA for Leqembi® Iqlik™ (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease under Fast Track status
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Leqembi Iqlik (lecanemab-irmb) subcutaneous autoinjector, as a weekly starting dose after the FDA granted Fast Track Status. This submission follows the approval of Leqembi Iqlik for maintenance dosing in the US on August 29. If approved for initiation dosing, Leqemb
About this update from Eisai Co., Ltd.
[{"type":"text","content":"STOCKHOLM, Sept. 3, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Leqembi Iqlik (lecanemab-irmb) subcutaneous autoinjector, as a weekly starting dose after the FDA granted Fast Track Status. This submission follows the approval of Leqembi Iqlik for maintenance dosing in the US on August 29. If approved for initiation dosing, Leqembi Iqlik would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners to treat this progressive, deadly disease.","length":723,"tagName":"p"},{"type":"text","content":"In the United States, Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). The sBLA is based on evaluation of subcutaneous (SC) lecanemab administration across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension, following the 18-month core study in individuals with early AD. Should the FDA approve the Leqembi Iqlik 500 mg SC dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once weekly starting dose, as an alternative to bi-weekly (every two weeks) intravenous (IV) dosing. This would expand the option for patients and care partners to receive Leqembi treatment from initiation to maintenance at home, offering a choice between IV and SC administration. The current injection time for each Leqembi Iqlik autoinjector takes approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment pathway.","length":1183,"tagName":"p"},{"type":"text","content":"Alzheimer's disease is a progressive, deadly disease with amyloid beta (Aβ) and tau as hallmarks that is caused by a continuous underlying neurotoxic process that begins before amyloid plaque removal and continues afterward.1,2,3 Only Leqembi fights Alzheimer's disease in two ways – targeting both amyloid plaque and protofibrilsi, which...