The US Food and Drug Administration (FDA) has approved Eisai’s biologics license application (BLA) for a subcutaneous version of lecanemab (LEQEMBI IQLIK) for maintenance treatment in early-stage Alzheimer’s disease.
The approval permits patients with mild cognitive impairment or mild dementia due to Alzheimer’s in the US to begin receiving weekly subcutaneous injections of LEQEMBI IQLIK starting from the first week of October 2025.
LEQEMBI IQLIK, developed by Eisai, is designed for easy administration with an autoinjector delivering a 360 mg dose in approximately 15 seconds. This follows an initial 18-month intravenous treatment phase at a dosage of 10 mg/kg every two weeks.
After this period, patients can choose between transitioning to the weekly subcutaneous injections or continuing with monthly intravenous infusions.
The FDA’s decision is based on findings from Phase 3 sub-studies within the Clarity AD open-label extension trial.
Over 600 patients participated in these studies. They demonstrated that the weekly subcutaneous injection maintains clinical and biomarker benefits comparable to those achieved with continued intravenous dosing for individuals with early Alzheimer’s disease.
Lecanemab, which has emerged from a research alliance between Eisai and BioArctic, is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody. It targets aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).
Alzheimer’s disease involves progressive cognitive decline associated with amyloid-beta and tau protein accumulation. Current treatments aim to slow this progression, and LEQEMBI IQLIK targets both amyloid plaque and protofibrils.
According to BioArctic, the subcutaneous option promises potential benefits such as reduced healthcare resource utilisation related to infusion preparation and monitoring, alongside enabling home administration.
BioArctic noted that the new administration method could reduce the burden of treatment by allowing use at home and minimising time spent at infusion centres. This could optimise healthcare resources by offering increased capacity for initiating treatment in new eligible patients while simplifying Alzheimer’s care pathways.
BioArctic CEO Gunilla Osswald said: “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.”
Eisai is responsible for the global clinical development and market approval processes for Leqembi, while BioArctic holds commercialisation rights in the Nordic region.
Currently, Leqembi is approved in several countries including the US, Japan, China, and across the European Union for the treatment of early-stage Alzheimer’s disease.
