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.
Eligible patients will now be able to transition to a maintenance dosing regimen of once every four weeks after receiving the drug once every two weeks for 18 months in the initiation phase, or may continue on the bi-weekly schedule.
Affecting almost seven million people in the US, AD is an irreversible, progressive neurodegenerative disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Leqembi works by binding to and reducing clumps of amyloid beta protein that form plaques in the brain. However, AD progression does not stop after plaque clearance, underscoring the importance of ongoing treatment.
The Supplemental Biologics License Application (BLA) submitted by Eisai, which serves as the lead for Leqembi’s development and regulatory submissions globally, was supported by a range of data, including modelling simulations predicting that changing to monthly maintenance dosing after 18 months will “maintain [the] clinical and biomarker benefits of the therapy”.
It is also hoped that the new regimen will make it easier for patients and their carers to continue treatment.
Beyond its IV formulation, Eisai and Biogen have an injectable version of Leqembi, which could reduce the need for hospital or infusion site visits and nursing care for IV administration.
The FDA accepted a BLA for the Leqembi subcutaneous autoinjector just two weeks ago for weekly maintenance dosing in patients who have completed the bi-weekly IV initiation phase, with the injection process expected to take 15 seconds on average.
The drug was also recently recommended by the European Medicines Agency’s human medicines committee in its IV form to treat adults with a clinical diagnosis of mild cognitive impairment and mild dementia due to AD who have one or no copies of the apolipoprotein E4 gene.