Following the news that Eisai and Biogen’s anti-amyloid beta (Aβ) monoclonal antibody (mAb) lecanemab was effective in reducing cognitive clinical decline among patients with early Alzheimer’s disease (AD) in the Phase III Clarity AD trial (NCT03887455);

Pippa Salter, Senior Neurology Analyst at GlobalData, a leading data and analytics company, offers her view:

“After multiple failures, and the controversial approval and messy launch of Biogen’s anti-Aβ mAb Aduhelm (aducanumab), lecanemab has finally demonstrated in a large-scale pivotal trial that targeting Aβ can be a successful way to treat AD. The primary endpoint that lecanemab met in the trial demonstrates that the drug is specifically effective for reducing cognitive decline. This is particularly important to lecanemab’s prospects, as it demonstrates that it has a significant clinical effect, unlike Aduhelm which failed to demonstrate this in its own clinical trials and was approved based on the surrogate endpoint of Aβ clearance.

“A known side effect of amyloid-lowering therapies is the development of amyloid-related imaging abnormalities (ARIAs), including ARIA related to underlying vasogenic edema (ARIA-E). In Clarity AD, the rate of ARIA-E was 12.5%, with symptomatic ARIA-E in just 2.8% of patients. Although incidence of ARIA could be a potential barrier for lecanemab, as it requires close monitoring of patients receiving the drug, when compared with Aduhelm, for which 35% of patients taking the approved dose of aducanumab developed ARIA-E, it represents a significant improvement. Not only does this give lecanemab a competitive advantage over Aduhelm but also over future potential competition such as Eli Lilly’s donanemab and Roche’s gantenerumab.

“Although Aduhelm should have first-to-market advantage, GlobalData expects lecanemab to be significantly more successful due to this Phase III data showing improved efficacy and safety. Additionally, Aduhelm has been facing uptake issues due to the US Centers for Medicare and Medicaid Services (CMS) limiting Medicare reimbursement of the product to AD patients participating in randomized controlled trials. GlobalData forecasts strong global (8MM*) sales for lecanemab of $2.76 billion by 2030.”

*8MM = US, France, Germany, Italy, Spain, UK, Japan, and China