Image shows an IV bag for the delivery of the approved amyloid-clearing drug, Leqembi. Photo: UW Medicine
On Monday, June 10, an FDA advisory panel unanimously supported Eli Lilly's drug donanemab, an amyloid-clearing drug designed to slow the progression of early Alzheimer’s disease, including mild cognitive impairment and mild Alzheimer’s dementia, finding that the treatment’s benefits outweigh the risks. This vote paves the way for an FDA decision, expected later this year.
Donanemab would become the second Alzheimer's drug in the U.S. that changes the course of the underlying disease and slows cognitive decline due to the disease, if the FDA agrees with the panel’s recommendation and grants approval. The FDA approved a similar drug, Leqembi, in July 2023.
"Donanemab was approved by the FDA advisory board of dementia experts, and thus, doctors are likely to prescribe this medication as an alternative to lecanemab once formally approved by the FDA, said MBWC Clinical Trials Director, Michael Rosenbloom, MD. "Donanemab's compelling clinical trial outcome not only confirms that this treatment strategy is effective in treating Alzheimer's disease, but also provides clinicians additional opportunities to tailor the amyloid monoclonal antibody to the individual patient. For instance, one patient may prefer to undergo fewer infusions, in which case donanemab may be the preferred choice; whereas, another patient may be at greater risk for amyloid related imaging abnormalities, in which case a drug such as lecanemab may be more desirable. The fact that we now have a new class of Alzheimer's drugs is a testament to the rapid advancement of Alzheimer's therapeutics."
As with all amyloid-clearing drugs, the main safety concern with donanemab is ARIA, or brain swelling and bleeding. The advisory panel commented on the need for physician and patient awareness about these safety risks, particularly for patients with the APOE4 gene variant.
Learn more:
- FDA Briefing Document
- Watch the June 10, 2024 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS): At this meeting, the Committee discusses the license application for donanemab intravenous infusion, submitted by Eli Lilly and Company, for the treatment of early symptomatic Alzheimer’s disease.
New MBWC Publication on Amyloid-Clearing Therapeutics:
Rosenbloom MH, O'Donohue T, Zhou-Clark D, Mala D, Frazier A, Tarrant M, Modrijan M, Riveira M, Chapman D, Griffin Y, Shakalis L, Grabowski TJ. A Framework for the Administration of Anti-amyloid Monoclonal Antibody Treatments in Early-Stage Alzheimer's Disease. CNS Drugs. 2024 Jul.
