The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's Alzheimer's drug Leqembi, the companies said on Monday.

The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's Leqembi (lecanemab-irmb) for maintenance dosing once every four weeks for the early stages of Alzheimer's disease.

The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for patients with Alzheimer’s, could help with Leqembi’s thus far disappointing uptake and sales.

Eisai and Biogen have secured US Food and Drug Administration approval for a once-monthly intravenous maintenance dosing regimen for Leqembi (lecanemab).

Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with Alzheimer disease administered Leqembi.

Biogen and Eisai’s Alzheimer’s disease (AD) drug Leqembi (lecanemab-irmb) has been approved by the US Food and Drug Administration (FDA) for monthly maintenance dosing. The anti-amyloid drug was granted traditional approval in the US in July 2023 for use as an intravenous (IV) infusion in patients with mild cognitive impairment or early-stage AD.