FDA Approves Eli Lilly’s Donanemab for Early-Stage Alzheimer’s Treatment

On July 2, 2024, the U.S. Food and Drug Administration (FDA) approved Eli Lilly's donanemab, marketed as Kisunla, for the treatment of early-stage Alzheimer's disease. This approval introduces a new therapeutic option for patients in the initial phases of this neurodegenerative condition.

Donanemab is a monoclonal antibody designed to target and clear beta-amyloid plaques in the brain, which are associated with the progression of Alzheimer's disease. Clinical trials have demonstrated that Kisunla can slow cognitive decline by approximately 29% compared to a placebo. The treatment involves monthly intravenous infusions, with the possibility of discontinuation once amyloid plaques are cleared, potentially reducing long-term treatment costs. However, the drug carries risks, including brain swelling and bleeding, necessitating regular MRI monitoring. Priced at about $32,000 annually, Kisunla is slightly more expensive than its competitor, Leqembi, which costs $26,500 per year. Medicare is expected to cover most patients prescribed donanemab.

The FDA's approval of Kisunla follows unanimous recommendations from its external advisory committee, which concluded that the benefits of donanemab outweigh its risks for patients in the early stages of Alzheimer's disease. This approval provides a new treatment option for the approximately 6 million Americans affected by Alzheimer's disease.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) approved Kisunla in October 2024. However, the National Institute for Health and Care Excellence (NICE) deemed the drug too expensive and requiring more evidence of its value, leading to the National Health Service (NHS) not covering its cost. Consequently, Kisunla is available only through private channels in the UK.

Eli Lilly and Company, founded in 1876, is a global pharmaceutical firm headquartered in Indianapolis, Indiana. The company has a long history of developing treatments for various diseases, including diabetes, cancer, and now Alzheimer's disease. In recent years, Eli Lilly has expanded its portfolio through acquisitions and collaborations, focusing on innovative therapies.

The approval of Kisunla marks a significant advancement in the treatment of Alzheimer's disease, offering patients and healthcare providers a new option to manage the condition. As with all medical treatments, it is essential for patients to consult with their healthcare providers to determine the most appropriate course of action based on individual circumstances.