Eisai and Biogen’s lecanemab (BAN2401) and Eli Lilly’s donanemab have recently received breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease (AD). The potential approval of lecanemab and donanemab will increase the number of disease-modifying treatments (DMTs) available that target and affect the underlying disease progression of AD, says GlobalData, a leading data and analytics company.
Christie Wong, Pharma Analyst at GlobalData comments: “The AD competitive landscape is saturated with symptom-based therapies with modest efficacy and primarily off patent, leaving ample room for new entrants into the AD market. Biogen’s Aduhelm (aducanumab), which was approved in June, is the first and only AD DMT to receive FDA approval, and GlobalData forecasts that Aduhelm will generate $5.5bn globally by 2027.”
Lecanemab and donanemab could be the next two anti-amyloid agents to receive FDA approval. It is anticipated that lecanemab and donanemab will be launched in 2023 and 2024 in the US, respectively. However, both pipeline candidates will need to demonstrate long-term safety, tolerability and efficacy profiles in Phase III clinical trials involving study periods of over 76 weeks. GlobalData forecasts that lecanemab and donanemab will generate global sales of $684m and $858m, respectively, by 2026.
Wong continues: “Lecanemab acts by selectively binding, neutralizing and eliminating soluble amyloid-beta (Aβ) monomers. In contrast, donanemab targets a modified form of Aβ, N3pG, that is aggregated in amyloid plaques. Reduction of these toxic proteins is believed to be of significant clinical value in AD and treating the disease in the early stages. However, early diagnosis is imperative for efficacious amyloid-based therapies. Despite the increase in the level of research on reliable biomarkers in the past few years, efficient diagnosis and monitoring of disease pathophysiology of AD in the prodromal, early stages of AD remains an important unmet need.
“Concerns regarding the development of amyloid-related imaging abnormalities (ARIAs) could represent a barrier for the uptake of monoclonal antibodies (mAbs) against Aβ. Physicians will be obliged to conduct regular MRIs to determine if patients have ARIA reactions. With consideration of the high costs of biologics and regular MRI scans, the uptake of anti-amyloid DMT could be limited.”