FDA Approves LEQEMBI IQLIK to Treat Early Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) has approved the biologics license application for once weekly lecanemab-irmb subcutaneous injection (LEQEMBI IQLIK, pronounced “I Click”) for maintenance dosing. LEQEMBI IQLIK is a subcutaneous autoinjector (SC-AI) developed by Eisai, containing 360 mg/1.8 mL (200 mg/mL) that can be administered in approximately 15 seconds. 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. After 18 months of LEQEMBI (lecanemab-irmb) 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 start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector.

Approval is based on LEQEMBI subcutaneous (SC) sub-studies of the Phase III Clarity AD open-label extension trial in individuals with early AD, which evaluated the safety of the LEQEMBI IQLIK autoinjector in more than 600 patients at a range of doses. Forty nine patients received a weekly 360 mg subcutaneous maintenance dose after at least 18 months of 10 mg/kg IV every two weeks. Importantly, none of these patients experienced any local or systemic injection-related adverse events (AEs).

Across all subcutaneous doses, the safety profile was similar to that of the IV maintenance treatment with one key difference: systemic reactions were much less common with subcutaneous dosing — less than one percent compared to approximately 26 percent with IV infusions. Approximately 11 percent of patients experienced mild-to-moderate local reactions (such as redness, swelling or itching at the injection site), which did not interfere with continued administration, and less than one percent had mild systemic symptoms such as headache, fever or fatigue.

Amyloid-related imaging abnormalities (ARIA) rates in patients who received a weekly 360 mg subcutaneous maintenance dose were similar to ARIA rates reported in patients who continued with the IV dose after 18 months and are similar to the background rates of ARIA in patients without treatment. ARIA is usually asymptomatic, although serious and life-threatening events can occur; however, it can be fatal. Most ARIA with LEQEMBI occurs within the first six months of IV initiation treatment.

Data from the study shows 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.