The US Food and Drug Administration (FDA) has approved Eisai and Biogen’s Supplemental Biologics License Application for once every four weeks intravenous (IV) maintenance dosing of LEQEMBI (lecanemab-irmb) for early Alzheimer’s disease (AD).
This decision may simplify the treatment process for patients and care partners.
LEQEMBI, designed for patients with mild cognitive impairment (MCI) or mild dementia due to AD, offers two dosing schedules. After an initial phase of once every two weeks for 18 months, patients can transition to the four-week dosing regimen.
The FDA’s decision is based on data from phase 2 and Clarity AD studies. These studies show that the new regimen maintains the treatment’s clinical and biomarker benefits.
AD is a relentless disease caused by a continuous neurotoxic process. LEQEMBI uniquely combats AD by clearing both protofibrils and plaque. This dual action is vital as protofibrils can continue to injure neurons even after plaque clearance.
Data highlight the importance of ongoing treatment. Discontinuation can lead to the reaccumulation of amyloid and a return to the placebo rate of clinical decline. Patients on the once every four weeks regimen may find it easier to continue treatment, potentially slowing disease progression and prolonging the benefits.
In the Clarity AD study, LEQEMBI reduced cognitive decline significantly compared to placebo over three years. This outcome underscores the treatment’s clinical benefit for early AD patients.
LEQEMBI is approved in multiple countries and has received a positive opinion from the European Medicines Agency. Eisai leads the development and regulatory submissions globally, co-commercialising with Biogen.
Katsuya Haruna, Group Officer & Executive Vice President, US Business Operations at Eisai, reflected: “The approval of the IV maintenance dosing regimen for LEQEMBI is an important step forward for patients and caregivers seeking to manage the progressive nature of Alzheimer’s disease. Maintenance dosing with LEQEMBI provides patients greater treatment flexibility while allowing patients to continue to benefit from therapy.”
