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Eisai and Biogen Announce U.S. Availability of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer's Disease
Globenewswire· 2025-10-06 20:30
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]
Eisai and Biogen Announce U.S. Availability of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer’s Disease
Globenewswire· 2025-10-06 20:30
Core Insights - Eisai Co., Ltd. and Biogen Inc. have launched 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] Product Information - LEQEMBI IQLIK is the first anti-amyloid treatment approved by the U.S. FDA for at-home injection after 18 months of intravenous treatment [1] - Patients can transition from intravenous infusions to a weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector [1][36] - The treatment is indicated for patients with Mild Cognitive Impairment (MCI) or mild dementia, collectively referred to as early Alzheimer's disease [10] Companion Program - The LEQEMBI Companion program aims to enhance patient access and support, offering resources such as injection training and a tracking tool [2][3] - The program includes a digital app developed with Medisafe, providing educational information and tracking capabilities for patients and caregivers [3] Financial Assistance - Eisai's Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost to eligible uninsured and underinsured patients [4] Clinical Data - In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) by 27% at 18 months compared to placebo [35] - The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was significantly better in the lecanemab group compared to placebo [35] Safety Profile - The safety profile of LEQEMBI IQLIK for maintenance treatment is similar to that of intravenous LEQEMBI, with a lower incidence of systemic reactions [31][36] - Common adverse reactions include infusion-related reactions (IRRs), ARIA-H, ARIA-E, headache, and nausea/vomiting [31][35]