Eisai and Biogen have announced FDA approval of LEQEMBI IQLIK (lecanemab-irmb) for maintenance dosing in early Alzheimer’s disease. The subcutaneous autoinjector delivers a 360 mg dose in approximately 15 seconds and will be launched in the US on 6 October 2025.
LEQEMBI IQLIK is indicated for patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease. Following 18 months of intravenous treatment, patients may continue with monthly IV infusions or switch to the new weekly subcutaneous injection.
The approval is based on sub-studies from the phase 3 Clarity AD open-label extension trial. Eisai stated: “Data shows that transitioning to the weekly LEQEMBI IQLIK autoinjector after 18 months of the initiation dose (10 mg/kg IV every two weeks) maintains clinical and biomarker benefits comparable to continued IV dosing.”
Safety was evaluated in over 600 patients. Eisai reported: “None of these patients experienced any local or systemic injection-related adverse events.” Systemic reactions were “much less common with subcutaneous dosing—less than 1% compared to approximately 26% with IV infusions.”
ARIA rates were similar between patients receiving subcutaneous and IV maintenance doses. Eisai noted: “Most ARIA with LEQEMBI occurs within the first 6 months of IV initiation treatment.”
LEQEMBI targets both amyloid plaque and protofibrils. Eisai said: “Maintenance treatment with once-weekly SC injection or once every four weeks of IV therapy offers patients options to continue slowing the disease progression and prolong the benefit of therapy.”
In the Clarity AD core study, lecanemab showed a mean change of -0.45 on the CDR-SB scale after 18 months. At 48 months, cognitive decline was reduced by -1.75 points compared to the ADNI cohort and -2.17 points versus the BioFINDER cohort.
