Edited by Aaron Sheinin
July 9, 2024 -- The FDA has approved Eli Lilly's new treatment, donanemab (branded as Kisunla), for adults grappling with early symptomatic Alzheimer's disease. This approval covers those with mild cognitive impairment or mild dementia, confirmed to have amyloid pathology, a hallmark of Alzheimer’s.
According to Eli Lilly, donanemab is the first therapy targeting amyloid plaques that can be stopped once these plaques are removed. This could potentially reduce treatment costs and the number of required infusions.
"This is real progress. Today's approval allows people more options and greater opportunity to have more time," remarked Joanne Pike, doctor of public health and president and CEO of the Alzheimer's Association.
The FDA's decision followed a unanimous recommendation from an advisory panel, which found that donanemab is effective and its benefits outweigh the risks for patients with early symptomatic Alzheimer's.
Approval was based on promising results from a phase 3 trial that demonstrated significant reductions in amyloid plaque burden and slower cognitive decline compared to placebo.
"This approval marks another step forward in evolving the standard of care for people living with Alzheimer's disease," said Howard Fillit, MD, co-founder of the Alzheimer's Drug Discovery Foundation, emphasizing the potential to reduce treatment costs because the therapy can be stopped once the plaque is removed.
Donanemab is set to cost $695 per vial, or $12,522 for a 6-month course, $32,000 for 12 months, and $48,696 for 18 months, although actual patient costs will depend on insurance coverage.
Like similar therapies, donanemab carries risks, including amyloid-related imaging abnormalities (ARIAs), which can cause brain edema and bleeding. The FDA panel deemed those risks are manageable.
The consensus among experts is that while donanemab has shown to be effective, careful monitoring and patient education about potential risks are crucial.
"If donanemab is approved, it will be important to minimize risk of ARIA with careful MRI monitoring and to have detailed discussions with patients and care partners," said Reisa Sperling, MD, from Brigham and Women's Hospital and Harvard Medical School in Boston.
In summary, the FDA's approval of donanemab represents a significant advance in Alzheimer's treatment, offering new hope and options for patients and their families facing this challenging disease.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
