Today, the US Food and Drug Administration granted full clinical approval to Eli Lilly to market donanemab, brand name KISUNLA, for the treatment of early Alzheimer’s disease, including Mild Cognitive Impairment (MCI) or mild dementia. Donanemab is a monoclonal antibody against the beta-amyloid protein that accumulates in the brain of people with Alzheimer’s disease. This represents the second ever full approval for a drug that directly targets the biology of Alzheimer’s disease. Image by Andrew Harnik/AP Donanemab was shown in a Phase 2 and then in a Phase 3 trial to have a significant impact on brain amyloid burden. In…

A June 17 article in the Los Angeles Times highlighted an important safety risk associated with the new class of medications recently approved for treating Alzheimer’s disease. The drugs are anti-amyloid monoclonal antibodies and include aducanumab, donanemab, and lecanemab. Of these, only lecanemab has achieved full FDA approval at the time of writing. The side effects are collectively known as amyloid-related imaging abnormalities, or ARIA, and are potential side effects for each of these drugs, though with differential frequencies observed across the clinical trials of these medications. The specific drug side effects include what are often referred to as bleeding…

The U.S. Food and Drug Administration. Today, the FDA convened its Peripheral and Central Nervous System Drugs Advisory Committee to review the data from pivotal clinical trials of donanemab, a monoclonal antibody against the beta amyloid protein that accumulates in the brain of people with Alzheimer’s disease. One of these trials was conducted at UCI MIND. The efficacy of donanemab in treating early Alzheimer’s disease in people with Mild Cognitive Impairment and mild dementia due to Alzheimer’s disease is largely agreed to have been demonstrated. The bulk of the discussion at the meeting emphasized other aspects, such as the safety…

For patients experiencing cognitive decline due to Alzheimer’s Disease (AD), choosing the most appropriate treatment course at the right time is of great importance. A key element to these decisions is the careful consideration of the available scientific evidence, particularly from randomized clinical trials (RCTs) such as the recent lecanemab trial. Translating RCT results into patient-level decisions, however, can be challenging. This is because trial results tell us about the outcomes of groups rather than individuals. A doctor must judge how similar their patient is to the groups studied in trials. For AD, where patients vary widely in clinical presentations…