FDA Approves Monthly Lecanemab for Early-Stage Alzheimer Disease: Daily Dose

_{©New Africa/AdobeStock}

Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

Last week, we reported on on the US FDA approval of monthly intravenous (IV) dosing of lecanemab (Lequembi) to treat early-stage Alzheimer disease (AD) with confirmed presence of ß-amyloid.

The approval

The US FDA approved the Supplemental Biologics License Application for once every 4 weeks lecanemab-irmb intravenous maintenance dosing. It is indicated for the treatment of AD in patients with mild cognitive impairment or mild dementia stage of disease in the US.

For individuals who have completed the 18-month induction phase of biweekly lecanemab infusions, the maintenance regimen calls for a monthly IV dose to maintain a concentration of the drug that sustains clearance of highly toxic protofibrils, precursors to the ß-amyloid plaque that induction treatment has cleared from the brain.

Clarity AD, the foundational trial for the FDA approval, evaluated 1795 patients with AD who had mild cognitive impairment or mild dementia and a confirmed presence of ß-amyloid pathology. Results showed that lecanemab met its primary end point of change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) score, with treated patients demonstrating a statistically significant 27% reduction in cognitive and functional decline vs placebo. The biweekly IV infusion also slowed disease progression by 24%, decline in activities of daily living by 37%, and decline of cognitive function by 26%.

Prescribing information for lecanemab including a warning for amyloid-related imaging abnormalities, or ARIA, which are know to occur with antibodies in this drug class.

Click here for more details.