Edited by Aaron Sheinin
July 9, 2024 – The FDA approved Eli Lilly's recent treatment donanemab (brand name Kisunla) for adults affected by early-stage Alzheimer's disease. This approval is for individuals with mild cognitive impairment or mild dementia who've confirmed amyloid pathology, a trademark of Alzheimer's disease.
According to Eli Lilly, donanemab is the primary therapy that targets amyloid plaques and could be stopped once those plaques are removed, potentially reducing the fee of treatment and the variety of infusions required.
“This is real progress. Today's approval gives people more options and the opportunity to have more time,” noted Joanne Pike, a public health physician and president and CEO of the Alzheimer's Association.
The FDA's decision followed a unanimous advice from an advisory panel that found that donanemab was effective and its advantages outweighed the risks for patients with early-stage Alzheimer's disease.
The approval was based on promising results from a Phase 3 study that showed a major reduction in amyloid plaque burden and slower cognitive decline in comparison with placebo.
“This approval represents another step forward in advancing the standard of care for Alzheimer's patients,” said Dr. Howard Fillit, co-founder of the Alzheimer's Drug Discovery Foundation, emphasizing the potential to scale back treatment costs because therapy could be stopped after plaques are removed.
The cost of donanemab is anticipated to be $695 per vial, or $12,522 for six months of treatment, $32,000 for 12 months of treatment, and $48,696 for 18 months of treatment, although the actual cost to the patient will depend upon insurance coverage.
As with similar therapies, there are risks related to donanemab, including amyloid-related imaging abnormalities (ARIAs), which may cause brain edema and bleeding. The FDA panel found these risks to be manageable.
There is a consensus amongst experts that while donanemab has been shown to be effective, careful monitoring and educating patients about potential risks are crucial.
“If donanemab is approved, it will be important to minimize the risk of ARIA through careful MRI monitoring and extensive discussions with patients and care partners,” said Dr. Reisa Sperling of Brigham and Women's Hospital and Harvard Medical School in Boston.
In summary, the FDA approval of donanemab represents a major advance in Alzheimer's disease treatment and offers recent hope and options to patients and their families facing this difficult disease.
Several editorial tools, including AI, were used to create this text. Human editors reviewed the content before publication.