Health
US FDA approves Leqembi® IQKLIK™ (lecanemab-irmb) subcutaneous injection for maintenance dosing for the treatment of early Alzheimer's disease
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA-B) partner Eisai announced today the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab subcutaneous injection for maintenance dosing. LEQEMBI IQLIK autoinjector is indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, collectively referred to as early AD, in the U.S. LEQEMBI IQLIK will b
About this update from Bioarctic Ab Class B
[{"type":"text","content":"STOCKHOLM, Aug. 29, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA-B) partner Eisai announced today the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab subcutaneous injection for maintenance dosing. LEQEMBI IQLIK autoinjector is indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, collectively referred to as early AD, in the U.S. LEQEMBI IQLIK will be launched on October 6, 2025.","length":579,"tagName":"p"},{"type":"text","content":"The U.S. brand name for the subcutaneous autoinjector is LEQEMBI IQLIK (pronounced "I Click"). After 18 months of Leqembi intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector.","length":349,"tagName":"p"},{"type":"text","content":"Alzheimer's disease is a progressive, relentless disease with Aβ and tau as hallmarks. It progresses in stages that increase in severity over time, and each stage of the disease presents different challenges for those living with the disease and their care partners. There is a significant unmet need for new treatment options that slow the progression of Alzheimer's disease from its early stage and reduce the overall burden on people affected by Alzheimer's disease and society. Only Leqembi fights Alzheimer's disease (AD) in two ways - targeting both amyloid plaque and protofibrils[1], which can impact tau accumulation downstream.[2],[3] Due to the re-accumulation of AD biomarkers and a return to a placebo rate of decline after therapy is stopped, maintenance treatment offers patients options to slow the disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer.","length":954,"tagName":"p"},{"type":"text","content":""Eisai's continued work to support and simplify patient and healthcare administration and treatment is an important work to help remove potential bottlenecks in healthcare and broaden patient population while supporting a sustainable long-term cost of treatment," says Gunilla Osswald, CEO at BioArctic. ",...