June 11, 2024 – An FDA advisory panel unanimously gave a green light on Monday to the Alzheimer’s disease treatment donanemab for use during early stages of the disease.
The move makes it likely that the FDA will fully approve this monoclonal antibody drug. Donanemab targets the buildup of plaques in the brain that are an indicator of the severe form of dementia.
The FDA had been expected to consider approving donanemab earlier this year as part of its fast track program. However, it delayed the decision and instead sought input during a meeting of independent experts.
Clinical trial results published last year suggested that the treatment could slow progression of the disease by a matter of months. This was based on people’s performance on tests that measure abilities related to cognition and to daily living skills, such as driving and managing finances. Some experts have characterized the treatment’s effects as modest.
Committee members on Monday discussed how the complex determination of effectiveness was made.
In the trial, participants received monthly infusions for about a year and a half. Three people in the clinical trial died. The treatment can cause brain swelling or brain bleeding.
Ultimately, advisors agreed that donanemab is safe and that the treatment’s benefits outweigh the risks.
One estimate suggests the out-of-pocket annual cost of regularly getting donanemab infusions would be about $6,600 for people on Medicare.
If fully approved, donanemab would join another recently approved monoclonal antibody treatment for Alzheimer’s disease called lecanemab. This drug also targets plaques and was approved by the FDA in July 2023.
Leaders from the Alzheimer’s Association applauded the panel’s decision.
“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO, in a statement.
An estimated 6 million people have Alzheimer’s disease, and there currently is no known way to fully prevent the disease or cure it.
