FDA

FDA OKs monthly IV maintenance dosing of Leqembi for patients with early Alzheimer's

January 28, 2025

FDA has approved Leqembi (lecanemab-irmb) for monthly IV maintenance dosing in patients with early Alzheimer's disease (AD), including those with mild cognitive impairment or mild dementia. According to the updated Prescribing Information, after 18 months of the biweekly initiation phase (10 mg/kg q2wks), patients may either transition to a maintenance dose of 10 mg/kg q4wks or continue 10 mg/kg q2wks. Approval of the new maintenance dosing option was based on data from phase 2 and 3 studies, which showed that transitioning to the less frequent dosing regimen maintains clinical and biomarker benefits.

According to a manufacturer press release, the new dosing schedule may be more convenient for patients and caregivers, potentially improving adherence and long-term outcomes.

Sources:

(2025, January 27). Eisai. FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease [News release]. https://www.eisai.com/news/2025/news202506.html

Eisai Co., Ltd. Leqembi (lecanemab-irmb) prescribing information. Accessed January 27, 2025. https://www.leqembi.com/-/media/Files/Leqembi/Prescribing-Information.pdf