The FDA has approved a new titration regimen for donanemab (Kisunla – Lilly), an IV amyloid beta-directed monoclonal antibody indicated for treatment of Alzheimer's disease. The new regimen is intended to reduce the risk of serious amyloid-related imaging abnormalities (ARIA) associated with use of the drug.

The FDA has cleared the Lumipulse G pTau217/ β-Amyloid 1-42 Plasma Ratio (Fujirebio), a bloodbased diagnostic test, for early detection of amyloid plaque pathology associated with Alzheimer's disease (AD) in adults ≥50 years old who are showing signs and symptoms of the disease. The new assay is the first blood test for amyloid biomarkers to become commercially available in the US. The Lumipulse G β-Amyloid Ratio (1-42/1-40), which measures amyloid biomarkers in cerebrospinal fluid (CSF), was cleared by the FDA in 2022.

Donanemab-azbt (Kisunla – Lilly), an IV amyloid beta-directed monoclonal antibody, has been approved by the FDA for treatment of Alzheimer's disease (AD). The label states that the drug should only be started in patients with mild cognitive impairment (MCI) or mild dementia. Donanemab is the third IV amyloid beta-directed monoclonal antibody to be marketed in the US. Lecanemab (Leqembi – Biogen/Eisai) was approved by the FDA in 2023 for the same indication as donanemab. Aducanumab (Aduhelm – Lilly) was granted accelerated approval in 2021, but it was withdrawn from the market earlier this year for commercial reasons.

View the Table: Amyloid-Directed Antibodies for Alzheimer's Disease

View the Comparison Table: Drugs for Alzheimer's Disease