June 11, 2024 – An FDA advisory panel on Monday unanimously gave the green light to using the Alzheimer's drug donanemab in early stages of the disease.
This move makes it likely that the FDA will fully approve this monoclonal antibody drug. Donanemab targets the formation of plaques within the brain, that are an indicator of the severe type of dementia.
The FDA was presupposed to consider approving donanemab earlier this yr as a part of its Fast Track program. However, it postponed the choice and as an alternative made a Meeting of independent experts.
Results of clinical studies A study published last yr suggested that the treatment could slow the progression of the disease by several months. That study was based on participants' scores on tests measuring cognitive abilities and day by day living skills akin to driving and handling funds. Some experts have described the treatment as Impact as modest.
On Monday, committee members discussed how the complex determination of effectiveness was carried out.
As a part of the study, participants received monthly infusions for a couple of yr and a half. Three participants within the clinical study died. The treatment can result in brain swelling or brain bleeding.
Ultimately, the consultants agreed that donanemab is secure and that the advantages of treatment outweigh the risks.
One treasure suggests that the annual out-of-pocket cost for normal donanemab infusions for Medicare beneficiaries can be roughly $6,600.
If fully approved, donanemab would join one other recently approved monoclonal antibody treatment for Alzheimer's disease called lecanemab, which also targets plaques and was approved by the FDA in July 2023.
Representatives of the Alzheimer's Association welcomed the panel's decision.
“A future with more approved Alzheimer's treatments is a tremendous step forward for people who are eligible for these drugs. There is progress in treatment,” said Joanne Pike, DrPH, President and CEO of the Alzheimer's Association, in a opinion.
An estimated 6 million people have Alzheimer's disease and there may be currently no known approach to completely prevent or cure the disease.