Donanemab for Alzheimer's disease: from preclinical research to the clinical application.

Introduction: Donanemab (Kisunla) is a humanized IgG1 monoclonal antibody specifically targeting a modified form of β-amyloid found predominantly within plaques (characterized as N-terminal pyroglutamate Aβ). Recently, it has gained approval for the use in early-stage Alzheimer's disease (AD) encompassing mild cognitive impairment due to AD or mild AD with confirmed brain amyloid pathology.

Areas covered: This drug profile discusses donanemab's function, clinical effectiveness, safety, tolerability, health economics, access challenges, and future prospects. This article is based on systematic review that was derived from PubMed.

Expert opinion: Donanemab is the third monoclonal antibody introduced for the treatment of individuals in the early stage of AD. While critical dialog continues regarding the potential impacts and role of antibody therapies, its approval signifies considerable progress in addressing the underlying pathology of AD. The authors are confident in the potential of antibodies against Aβ as a promising treatment option and foresee exciting advancements. However, further research is needed on trials extending beyond 18 months of follow-up, postmarketing surveillance, and the application of donanemab in combination with existing treatments and lifestyle interventions. Additionally, significant knowledge gaps and implementation limitations persist and must be addressed.