Eisai Co., Ltd. announced that an article about long-term health outcomes of its investigational anti-amyloid-beta (Aβ) protofibril antibody lecanemab in people living with early Alzheimer’s disease (AD) using simulation modeling was published in a peer-reviewed journal Neurology and Therapy. In this simulation, lecanemab treatment is estimated to potentially slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of mild cognitive impairment (MCI) due to AD and mild AD (collectively, early AD).
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 disease simulation model (AD ACE model1,2) based on the results of a Phase IIb clinical trial (Study 201) evaluating the efficacy and safety of lecanemab. SoC data were estimated from ADNI (Alzheimer’s Disease Neuroimaging Initiative) 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 (SoC vs. lecanemab+Soc: 3.10 vs.5.61 years), 3.13 (6.14 vs. 9.27 years) and 2.34 (9.07 vs.11.41 years) respectively. 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. The incremental mean times for transition to mild and moderate AD dementia were 2.53 and 3.34 years, respectively, when treating MCI due to AD in a subgroup analysis compared to SoC.
“With an increasing and aging global population, the number of people diagnosed with Alzheimer’s disease will only continue to increase, making it an even more important and urgent public health priority. Alzheimer’s disease is growing issue in regard to medical and nursing care costs, but also costs of informal care by family, leading to increased anxiety. 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 Vice President, 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. As part of Eisai’s commitment to our human healthcare mission and transparency, we will continue to publish data and information about lecanemab.”
Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab’s rolling submission of a Biologics License Application 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 readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.