Core Insights - Eisai Co., Ltd. and Biogen Inc. have launched the LEQEMBI IQLIK, a subcutaneous injection for Alzheimer's disease maintenance treatment after an initial 18-month intravenous therapy [1][36] - The LEQEMBI Companion program has been introduced to provide additional resources and support for patients throughout their treatment journey [2][3] Group 1: Product Launch and Features - LEQEMBI IQLIK is the first anti-amyloid treatment approved by the U.S. FDA that allows at-home injections after 18 months of intravenous treatment [1] - Patients can choose between continuing intravenous infusions or switching to the new weekly 360 mg subcutaneous injection [1][36] - The LEQEMBI Companion app, developed with Medisafe, offers educational resources and a tracking tool for patients [3] Group 2: Patient Support Initiatives - The LEQEMBI Companion program aims to enhance access to treatment and provide resources for patients with early Alzheimer's disease [2] - Eisai's Patient Assistance Program will offer LEQEMBI at no cost to eligible uninsured and underinsured patients [4] Group 3: Clinical Efficacy and Safety - LEQEMBI targets both amyloid plaques and protofibrils, which are implicated in neurodegeneration [5][9] - Continuing maintenance treatment is essential to slow Alzheimer's disease progression and extend therapeutic benefits [6] - Clinical trials showed that treatment with lecanemab reduced clinical decline by 27% at 18 months compared to placebo [35] Group 4: Collaboration and Development - Eisai leads the global development and regulatory submissions for lecanemab, with Biogen co-commercializing the product [8][39] - The collaboration between Eisai and BioArctic has been ongoing since 2005, focusing on the development of Alzheimer's treatments [40]

Core Insights - LEQEMBI IQLIK is the first and only anti-amyloid treatment that allows for at-home injections, enabling patients and care partners to continue treatment after an initial 18-month intravenous therapy [1][2] - The U.S. FDA has approved the Biologics License Application for LEQEMBI IQLIK, which will be launched on October 6, 2025 [2][11] - The treatment is indicated for maintenance dosing in patients with mild cognitive impairment or mild dementia, following an initial 18-month intravenous treatment [2][16] Group 1: Treatment Mechanism and Efficacy - LEQEMBI targets both amyloid plaques and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease [4][12] - Clinical trials indicate that transitioning to the weekly LEQEMBI IQLIK autoinjector after 18 months maintains clinical and biomarker benefits comparable to continued intravenous dosing [5][40] - In the Clarity AD core study, treatment with lecanemab reduced clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) by 27% at 18 months compared to placebo [40] Group 2: Safety and Side Effects - The safety profile of LEQEMBI IQLIK is similar to that of intravenous treatment, with fewer systemic reactions reported [5][37] - Injection-related adverse events were less common with subcutaneous dosing, occurring in less than 1% of patients compared to approximately 26% with intravenous infusions [5][37] - The incidence of amyloid-related imaging abnormalities (ARIA) was similar between patients receiving the subcutaneous maintenance dose and those continuing with intravenous dosing [5][20] Group 3: Patient Support and Accessibility - Eisai offers various patient support programs in the U.S. to assist patients and care partners with treatment navigation and insurance coverage [9][10] - The Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost for eligible uninsured and underinsured patients [10] - The subcutaneous formulation is expected to reduce healthcare resource utilization associated with intravenous maintenance dosing, streamlining the overall Alzheimer's treatment pathway [8]