Eisai, Biogen announce FDA approval for Leqembi Iqlik BLA

Eisai (ESAIY) and Biogen (BIIB) announced that the FDA has approved the biologics license application for once weekly lecanemab-irmb subcutaneous injection for maintenance dosing. Leqembi Iqlik is a subcutaneous autoinjector developed by Eisai, containing 360 mg/1.8 mL that can be administered in approximately 15 seconds. Leqembi Iqlik autoinjector is indicated for maintenance dosing to treat Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease in the U.S. After 18 months of Leqembi intravenous 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.