Leqembi Maintenance Dosing Approved by the FDA

The Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for maintenance dosing with Leqembi (lecanemab-irmb; Eisai, Tokyo, Japan; Biogen, Cambridge, MA). The approval enables patients with early Alzheimer disease (AD) to receive Leqembi treatment by intravenous (IV) infusion once every 4 weeks at 10 mg/kg, following an 18-month initiation phase with treatment once every 2 weeks. Patients also have the option to continue the initiation phase dose of 10 mg/kg once every 2 weeks.

The approval was based on positive data from the phase 2 core study of Leqembi treatment (NCT01767311) and its long-term extension (LTE), as well as results from the phase 3 Clarity AD clinical trial (NCT03887455) and its LTE. Modeling data from these studies demonstrate that the clinical and biomarker benefits of biweekly Leqembi treatment can persist after transitioning to a once-monthly maintenance dosing schedule.

Results of the phase 2 core study show that discontinuing treatment with Leqembi may result in the reaccumulation of AD biomarkers and a reversion to the placebo rate of clinical decline. According to a statement from Biogen, Leqembi maintenance dosing may increase the ease of treatment for patients and their care partners, which may prolong the benefits of therapy.

Leqembi's label includes a Boxed Warning for amyloid-related imaging abnormalities (ARIA).