The current treatments for Alzheimer’s disease (AD) consist mostly of medications that are aimed at treating the symptoms of the disease. A novel disease-modifying therapy (DMT) that can demonstrate significant efficacy in clinical trials could revolutionize the AD market in a way that the anti-amyloid-beta (Aβ) monoclonal antibodies (mAbs) have been unable to do thus far, which highlights that there remains a significant unmet need for DMTs in the Alzheimer’s market, says GlobalData, a leading data and analytics company.

Pippa Salter, Senior Neurology Analyst at GlobalData, comments: “Despite the FDA approval of Biogen’s Aduhlem (aducanumab) in 2021, when it was hailed as the first DMT for AD, and the recent approval of Eisai/Biogen’s Leqembi (lecanemab) in January 2023, these new anti-Aβ mAb DMTs are yet to become widely available to patients, and have not, as yet, had the impact on the AD market as was hoped.

“The US Centers for Medicare and Medicaid Services (CMS) limited the Medicare reimbursement of Aduhelm, and subsequent similar products, to AD patients participating in randomized controlled trials only due to limited efficacy data seen in Aduhelm’s pivotal Phase III trials. The decision has resulted in low uptake and poor sales for Aduhelm. As the CMS has not lifted the restriction for Leqembi based on data from its accelerated approval, the initial uptake of Leqembi will be impacted until there is a potential change in coverage, if full approval is granted for the drug.”

Key opinion leaders (KOLs) previously interviewed by GlobalData indicated that, due to the lack of widely available DMTs, the development of an agent that can reverse or stop the underlying pathology of the disease is the most important area of need in the AD space.

Salter continues: “Since AD is highly complex, there is still an incomplete understanding of the molecular pathophysiology of the disease which means that there is no clear consensus on the mechanism of action (MOA) that has the highest potential as a DMT. This is reflected in the variety of MOAs with a potential disease-modifying action present in the late-stage AD pipeline, with more than 10 unique MOAs being targeted.”

It is widely accepted that early pharmaceutical intervention is key to slowing or possibly halting the progression of the disease. The diagnosis of AD at its earliest stage is important to allow the current medications to achieve their maximum therapeutic effect.

Salter concludes: “Patients in many areas are still reluctant to seek a diagnosis in the absence of highly efficacious DMTs, making it hard to achieve high rates of early diagnosis. Thus, the need to develop effective DMTs is critical. Furthermore, the approval of new DMTs will open the possibility for biomarkers to be approved and reimbursed, allowing for easier early detection and diagnosis of AD.”