Biogen and Eisai’s Alzheimer’s disease (AD) drug has been predicted to have a positive effect on long-term health outcomes, according to a new article published by Eisai in the journal Neurology and Therapy.
The analysis is based on a disease simulation model that used data from the phase 3 Clarity AD clinical trial, which evaluated the efficacy and safety of lecanemab, as well as published literature to simulate the natural progression of the disease.
The simulation showed that the estimated lifetime risk of disease progression to mild, moderate and severe AD dementia could potentially be reduced by 7.5%, 13.7% and 8.8%, respectively, in patients who received lecanemab plus standard of care (SoC), compared to those who received SoC alone.
Moreover, the study showed that lecanemab allowed around 5% of patients to avoid institutional care, and treatment resulted in a delay of two to three years in the mean time to progression to more severe stages of AD, compared with SoC alone.
Patients treated with lecanemab also experienced an increase of 0.71 quality-adjusted life-years compared to those receiving SoC, with QALYs for lecanemab-treated patients amounting to 4.39 years.
Ivan Cheung, senior vice president, and global Alzheimer’s disease officer of Eisai Co Ltd, chairman and chief executive officer of Eisai Inc, said: “These predicted and simulated long-term health outcomes provide insights for healthcare decision-makers regarding the potential clinical and socioeconomic value of lecanemab.
“Treatment with lecanemab may potentially provide a benefit over the current standard of care by delaying the progression of AD and potentially allowing people taking lecanemab to live independently longer, and improve their quality of life.”
Lecanemab, under the brand name Leqembi, was approved for certain AD patients in the US earlier this year through the accelerated approval pathway, under which the US Food and Drug Administration may approve drugs for serious conditions where there is an unmet medical need.
This decision was based on phase 2 data showing that Leqembi reduced the accumulation of amyloid beta plaque in the brain, a defining feature of Alzheimer’s disease.
The drug has since been granted priority review for traditional approval in the US, with the application supported by data from the phase 3 confirmatory Clarity AD clinical trial.
For lecanemab, Eisai serves as lead of development and regulatory submissions globally, with both companies commercialising and promoting the product, and Eisai having final decision-making authority.