Biogen and Eisai have announced the rolling submission to the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) for lecanemab.
The submission, made as part of the accelerated approval pathway programme, is to use lecanemab to treat mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD with confirmed presence of amyloid pathology in the brain.
As part of the completed submission, Eisai has requested a priority review.
Results from the lecanemab phase 3 confirmatory ‘Clarity AD’ clinical trial, involving 1,795 patients, will be reported later in 2022.
The FDA has agreed that the results of Clarity AD, when completed, will serve as the study used to verify the clinical benefit of lecanemab. Dependent upon the results of this analysis, Eisai may submit for full approval at some point this year.
The BLA submission for lecanemab is based on clinical, biomarker and safety data from the proof-of-concept phase 2b trial involving 856 people with early AD.
The large number of participants across these studies provides the FDA with extensive safety data. After 18 months of treatment, lecanemab reduced brain amyloid by a mean of 0.306 SUVr units – from a baseline mean of 1.37 – and over 80% of subjects became amyloid negative by visual read.
In addition, the extent of reduction in amyloid was matched with slower clinical decline on both the Alzheimer’s Disease Composite Score and the Alzheimer Disease Assessment Scale-Cognitive Subscale.
“We would like to thank the people living with early AD and the healthcare professionals who participated in the lecanemab study and for their cooperation in allowing completion of this BLA to the US FDA. Alzheimer’s disease is a progressive and devastating disease with few treatment options,” said Haruo Naito, chief executive officer at Eisai.
“Eisai employees have spent time with people living with Alzheimer’s disease and their families to truly understand their feelings and challenges and have been working to create new treatments for many years. Our comprehensive medicine creation approach along the Alzheimer’s disease continuum reflects Eisai’s long-term commitment to providing innovative treatments to the people living with AD, their families and healthcare professionals who urgently need new treatment options,” he added.