An expert panel recently gave its support for the FDA approval of a new drug for Alzheimer’s disease called donanemab, manufactured by Eli Lilly. The panel, made up of independent advisors to the FDA, voted unanimously in favor of the drug, stating that the benefits of the treatment outweigh the risks.
Alzheimer’s disease affects over six million Americans and currently has no cure. Donanemab showed modest benefits in slowing cognitive decline in patients in the early stages of the disease. However, the drug also comes with significant safety risks such as brain swelling and bleeding.
Despite the risks, the panel emphasized that the consequences of Alzheimer’s are severe, and even a modest benefit from the drug could be valuable. The FDA typically follows the advice of its advisory committees, but not always.
The drug is based on the theory that Alzheimer’s disease starts with the accumulation of amyloid protein in the brain, leading to neuron death. Donanemab aims to clear amyloid from the brain to treat Alzheimer’s. Two other similar drugs, Leqembi and Aduhelm, have been approved recently, with comparable risks and benefits to donanemab.
Leqembi, made by Eisai and Biogen, was approved last year, while Aduhelm, also made by Biogen, was approved in 2021 but later discontinued due to insufficient evidence of its benefits.
The approval of donanemab offers hope for those affected by Alzheimer’s disease, providing a potential treatment option for those in the early stages of the condition. While the drug comes with risks, the panel’s endorsement highlights the urgent need for effective treatments for Alzheimer’s patients. As research in the field continues to evolve, advancements like donanemab bring optimism for the future of Alzheimer’s treatment.