Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for LEQEMBI IQLIK (lecanemab-irmb) subcutaneous injection for maintenance dosing in early Alzheimer’s disease (AD).
LEQEMBI IQLIK is a once-weekly, subcutaneous autoinjector developed by Eisai, delivering 360 mg of the drug in a quick 15-second injection. It is indicated for patients with mild cognitive impairment or mild dementia stages of AD, collectively referred to as early AD.
Patients who have completed 18 months of intravenous LEQEMBI treatment at 10 mg/kg every two weeks can either continue with intravenous infusions once every four weeks or switch to the new weekly subcutaneous injection via the LEQEMBI IQLIK autoinjector.
This approval offers a more convenient maintenance treatment option, potentially improving patient comfort and adherence in managing early Alzheimer’s disease.