Leqembi Monthly IV Maintenance Dosing Approved for Early Alzheimer Disease 

The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the monthly intravenous (IV) maintenance regimen of Leqembi^® (lecanemab-irmb) for early Alzheimer disease.

Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. It reduces amyloid beta plaques in the brain, which is a defining pathophysiological feature of Alzheimer disease. 

The new approval allows patients to transition to the once every 4 weeks 10mg/kg dosing regimen following completion of the 18-month biweekly initiation phase. The sBLA  was based on modeling of observed data from the phase 2 Study 201 trial (ClinicalTrials.gov Identifier: NCT01767311) and its open-label extension phase, as well as the phase 3 Clarity AD study (ClinicalTrials.gov Identifier: NCT03887455) and its open-label extension phase. All studies included patients with Alzheimer disease with a confirmed presence of amyloid pathology and mild cognitive impairment or mild dementia.

Exposure-response modeling predicts that transitioning to a dose of lecanemab 10mg/kg every 4 weeks after 18 months of treatment with the 10mg/kg every 2 weeks dosing regimen will maintain clinical and biomarker therapy benefits such as reductions in amyloid beta plaque and plasma p-tau181 levels.

According to Eisai, a once every 4 weeks maintenance dosing regimen may be easier for patients and caretakers to continue. In a press statement, the Company emphasized the importance of ongoing treatment as data from the off-treatment period between the Study 201 trial and the long-term extension phase showed patients who stopped treatment reverted back to the placebo rate of clinical decline.

This article originally appeared on MPR