US FDA approves Alzheimer’s drug donanemab
The US FDA has approved donanemab for the treatment of early symptomatic Alzheimer’s disease.
After full data was shared from the Phase III trial in August 2023, the US FDA has approved the use of donanemab, developed by Eli Lilly and Company (IN, USA), to treat adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology. The drug is the third disease-modifying drug to be approved to treat AD and comes after the FDA’s advisory panel unanimously voted in June that the drug shows clinical benefit for treating AD.
Donanemab, sold under the brand name Kisunla™, is a monoclonal antibody that targets abnormal amyloid-β peptides in the brain. The Phase III trial, called TRAILBLAZER-ALZ 2, showed that donanemab reduced amyloid plaques by around 84% after 18 months of treatment. It slowed cognitive and functional decline by up to 35% compared to placebo and reduced participants’ risk of progressing to the next clinical stage of disease by up to 39%.
Once-a-month donanemab is the first and only AD therapy with evidence to support stopping treatment when amyloid plaques are removed, which can result in reduced costs and fewer infusions.
Like the other amyloid-targeting therapies, such as lecanemab and aducanumab, donanemab can cause amyloid-related imaging abnormalities (ARIA). ARIA refers to abnormal differences seen in MRI images of the brain, which can result in mild to severe bleeding or swelling in the brain. ARIA is a potential side effect that will need to be monitored.
“This approval marks another step forward in evolving the standard of care for people living with Alzheimer’s disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer’s community,” commented Howard Fillit, Co-Founder and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation (NY, USA). “As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients. Diagnosing and treating Alzheimer’s sooner than we do today has the potential to meaningfully slow disease progression, giving patients invaluable time to maintain their independence for longer.”
You might also like:
