Simulation model shows potential clinical value of Eisai drug for patients with early AD
An article reporting on the long health outcomes of Eisai’s investigational anti-amyloid-beta (Aβ) protofibril antibody, lecanemab, in people living with early Alzheimer’s disease (AD) using simulation modeling was recently published in Neurology and Therapy.
Lecanemab is an investigational humanized monoclonal antibody for Alzheimer’s disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic.
The therapy, according to the developers, involves selective binding to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates, which are thought to contribute to the neurodegenerative process in AD.
Eisai is collaborating with Biogen on the joint development and commercialization of AD treatments. Eisai serves as the lead on lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product.
“The findings from the simulation model suggest early treatment with lecanemab may delay progression to the more severe stages of AD, potentially giving people living with early AD and their loved ones more time together and possibly reducing healthcare costs,” said Ivan Cheung, chairman, Eisai Inc, senior VP and president, neurology business group and global Alzheimer’s disease officer, Eisai Co., Ltd. "These predicted and simulated long-term health outcomes provide insights for healthcare decision-makers regarding the potential clinical and socioeconomic value of lecanemab. Ongoing Phase 3 studies will soon be able to inform the model inputs and refine the findings.”
The simulation model
The article describes the comparison of the long-term clinical outcomes for the people living with early AD who have amyloid pathology with standard of care (SoC) alone (including stable use of acetylcholinesterase inhibitor or memantine), and with lecanemab with SoC (lecanemab+SoC), using the AD ACE simulation model, based on the results of a Phase 2b clinical trial evaluating the efficacy and safety of lecanemab.
SoC data were estimated from Alzheimer's Disease Neuroimaging Initiative (ADNI) study results. It was shown that the estimated lifetime risk of disease progression to mild, moderate, and severe AD dementia from baseline could potentially be reduced by 7%, 13% and 10% in lecanemab+SoC, respectively, compared to SoC.
In the model, the mean time advancing to mild, moderate, and severe AD dementia was longer for patients in the lecanemab-treated group than for patients in the SoC group by 2.51 years, as per the findings.
Subgroup analysis by age and disease severity at baseline also revealed a potentially greater impact on disease progression with earlier initiation of treatment with lecanemab, reads the study.
BLA application
Lecanemab was granted Breakthrough Therapy and Fast Track designations by the US Food and Drug Administration (FDA) in June and December 2021, respectively.
Eisai said it anticipates completing lecanemab’s rolling submission of a Biologics License Application (BLA) for the treatment of early AD to the FDA under the accelerated approval pathway in the first quarter of Eisai’s fiscal year 2022, which began April 1, 2022.
Additionally, the results of the Phase 3 confirmatory Clarity AD clinical trial will occur in autumn 2022, said the company.
