0
0
In a significant step towards advancing Alzheimer’s disease treatment, an FDA advisory panel unanimously endorsed the use of donanemab on Monday. The panel’s approval suggests that the FDA is likely to fully authorize this monoclonal antibody drug for early-stage Alzheimer’s, targeting brain plaques indicative of severe dementia.
Initially, the FDA had considered fast-tracking donanemab’s approval earlier this year but decided to seek further input from independent experts. This decision followed clinical trial results published last year, indicating that donanemab could slow the progression of Alzheimer’s by several months. The trials measured participants’ cognitive abilities and daily living skills, such as driving and managing finances. While some experts described the treatment’s benefits as modest, the panel ultimately agreed that its advantages outweigh the risks.
During the trials, participants received monthly infusions over approximately 18 months. Although three participants died, the advisors deemed donanemab safe, acknowledging potential side effects like brain swelling or bleeding.
The out-of-pocket annual cost for donanemab infusions could be around $6,600 for Medicare recipients. If approved, donanemab would join lecanemab, another monoclonal antibody targeting brain plaques, which received FDA approval in July 2023.
Leaders from the Alzheimer’s Association welcomed the panel’s decision. Joanne Pike, DrPH, president and CEO of the Alzheimer’s Association, expressed optimism, stating, “A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening.”
Currently, an estimated 6 million people are affected by Alzheimer’s disease in the United States, with no known way to fully prevent or cure the disease. The approval of treatments like donanemab and lecanemab marks a hopeful stride in managing and potentially mitigating the impact of Alzheimer’s on patients and their families.
