Tag: Donanemab

As of 2025, the U.S. Food and Drug Administration (FDA) has granted full approval to two amyloid antibodies for treating early-stage Alzheimer's disease: lecanemab (Leqembi) and donanemab (Kisunla) [1.2.1, 1.2.3, 1.2.4]. This article answers: **what amyloid antibodies are FDA approved** and details their use.

In January 2023, the U.S. Food and Drug Administration (FDA) initially rejected Eli Lilly's application for accelerated approval of its Alzheimer's drug, donanemab, citing a limited number of patients with adequate long-term data. This was not the only regulatory hurdle the treatment would face, as the European Medicines Agency (EMA) also refused authorization later due to an unfavorable risk-benefit assessment.

Three deaths were assessed as related to donanemab treatment due to amyloid-related imaging abnormalities (ARIA) during the TRAILBLAZER-ALZ 2 trial, prompting a closer examination of the drug's safety profile. The question of 'How many people died in the donanemab trial?' has become central to discussions surrounding this new Alzheimer's medication, balancing its efficacy with significant safety concerns.

In July 2024, the FDA granted traditional approval for **donanemab** (marketed as Kisunla™), a monoclonal antibody that targets and helps clear amyloid plaques in patients with early symptomatic Alzheimer's disease. This represents a significant advancement in treating the underlying pathology of the disease rather than just managing symptoms.

With a market capitalization exceeding $750 billion as of 2024, Eli Lilly is a global pharmaceutical leader. Answering the question, "What is the Eli Lilly drug?" is complex, as the company develops and markets a diverse portfolio of treatments. However, recent successes in metabolic and neurologic health have propelled drugs like Mounjaro, Zepbound, and Kisunla to the forefront of its identity.

The U.S. Food and Drug Administration (FDA) approved donanemab (brand name Kisunla) in July 2024 for treating early symptomatic Alzheimer's disease. This monoclonal antibody, developed by Eli Lilly, is specifically designed to target and help clear beta-amyloid plaques from the brain. Understanding the meaning of Donanemab involves grasping its innovative mechanism and potential to slow the disease's progression.