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.

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.

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's disease progression does not stop after plaque clearance; ongoing treatment with LEQEMBI can slow disease progression and prolong the benefits of therapy TOKYO and CAMBRIDGE,

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.

A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research shows.

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.