Patients prescribed donanemab will need to undergo regular MRI scans to monitor potential side effects, specifically brain bleeding and swelling. Donanemab, a significant advancement in Alzheimer’s treatment, is only the second drug of its kind to demonstrate effectiveness in slowing the progression of early-stage Alzheimer’s disease.
It is important to note that donanemab, marketed under the name Kisunla, is an amyloid antibody drug designed to target and reduce amyloid plaques in the brain, which are believed to play a crucial role in the development of Alzheimer’s. The approval of donanemab marks a significant milestone in Alzheimer’s research and treatment, offering new hope to patients and their families.
Clinical trials of donanemab have shown promising results. The drug slowed cognitive decline by 35 percent compared to a placebo, enabling individuals to maintain their daily activities for a longer period. This is particularly meaningful for patients in the early stages of Alzheimer’s, as it helps preserve their independence and quality of life.
However, while donanemab offers potential benefits, it also carries risks. One of the most concerning side effects is the potential for brain bleeding and swelling, known as amyloid-related imaging abnormalities (ARIA). Due to these risks, patients taking donanemab are required to undergo regular MRI scans. These scans are crucial for detecting any signs of ARIA early, allowing for timely intervention and management of the condition.
While donanemab represents a promising treatment option for early-stage Alzheimer’s, it also necessitates careful monitoring due to the associated risks. The requirement for regular MRIs underscores the importance of balancing the drug’s benefits with the need for vigilant medical supervision. As research continues, the medical community remains hopeful that donanemab and similar drugs will pave the way for even more effective treatments in the fight against Alzheimer’s disease.
FDA Approves Donanemab for Early-Stage Alzheimer’s Disease
In a significant development for Alzheimer’s treatment, the U.S. Food and Drug Administration (FDA) has granted approval to Kisunla (donanemab), a new drug designed to slow the progression of early-stage Alzheimer’s disease. This approval marks donanemab as the second drug of its kind, following Leqembi (lecanemab), that targets the underlying brain processes responsible for cognitive decline in Alzheimer’s patients. The FDA’s decision was supported by an advisory panel that endorsed the approval of Eli Lilly’s new drug last month.
“The trial data demonstrated, convincingly, that Kisunla reduces the rate of cognitive and functional decline in patients in the mild cognitive impairment and mild dementia stages of Alzheimer’s disease,” said Dr. Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. She added, “Today’s approval is evidence of the FDA’s commitment to helping more safe and effective drugs to treat Alzheimer’s disease become available.”
Amyloid Antibodies and Their Role in Alzheimer’s Treatment
Donanemab belongs to a class of drugs known as amyloid antibodies. These medications are designed to clear the brain of amyloid plaques, which are believed to contribute to the cognitive decline seen in Alzheimer’s disease. This approach is shared with lecanemab, another amyloid antibody. However, the first drug in this class, Aduhelm (aducanumab), faced controversy. Despite winning conditional FDA approval in 2021, Aduhelm did not receive full approval due to concerns about its efficacy and has since been discontinued.
Clinical trials for donanemab have shown promising results. In a late-stage trial involving 1,182 patients with early symptomatic Alzheimer’s, the drug slowed cognitive decline by 35 percent compared to a placebo. It also reduced the decline in daily living activities, such as driving, managing finances, and engaging in hobbies, by 40 percent. These findings, published in the Journal of the American Medical Association (JAMA), underscore donanemab’s potential to help patients maintain their independence for a longer period.
Risks of Brain Bleeding and Swelling
Despite its benefits, donanemab is not without risks. One of the primary safety concerns associated with amyloid antibodies like donanemab is the occurrence of amyloid-related imaging abnormalities (ARIA). ARIA can appear on brain scans and may involve seizures, brain swelling, or bleeding. The New England Journal of Medicine talks about the late-stage trial in detail. While some individuals may experience severe symptoms, many do not exhibit any noticeable effects.
In the late-stage trial, 37 percent of patients taking donanemab experienced some form of ARIA, including brain bleeding or swelling. Similar side effects were observed in trials for lecanemab, with 17 percent of participants experiencing brain bleeding and 12 percent experiencing brain swelling. Lawrence Honig, MD, PhD, a neurologist at NewYork-Presbyterian/Columbia University Irving Medical Center, emphasizes that the likelihood of experiencing noticeable symptoms from ARIA is relatively low. “Most people aren’t going to get side effects that are symptomatic with ARIA,” he says. “The likelihood of symptomatic side effects that you feel and you notice or your family notices is less than 10 percent even for those most at risk.”
Monitoring and Cost Considerations
Given the risks associated with ARIA, patients taking donanemab will need regular magnetic resonance imaging (MRI) scans to monitor for any signs of brain bleeding or swelling. This requirement for ongoing monitoring is essential to ensure that any adverse effects are detected and managed promptly.
While the risk of ARIA is slightly higher with donanemab than with lecanemab, some patients may still prefer donanemab due to its monthly infusion schedule, compared to lecanemab’s bi-weekly administration. However, as Dr. Honig points out, lecanemab may be more accessible initially due to its longer presence on the market and potentially more readily available supply.
The cost of donanemab is also a consideration for patients and their families. According to a company press release, the drug will be priced at $695 per vial, amounting to approximately $32,000 for a 12-month treatment course. The actual cost to patients will vary depending on their insurance coverage and the duration of treatment required.
The FDA’s approval of donanemab represents a significant step forward in the fight against Alzheimer’s disease, offering new hope to patients and their families. As with any new treatment, the benefits must be carefully weighed against the risks, and ongoing monitoring will be crucial to ensuring patient safety.
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