FDA Approves Eli Lilly's New Drug for Early Alzheimer's …C0NTINUE READING HERE >>>
Key Takeaways
The FDA approved Eli Lilly's donanemab, a monoclonal antibody drug for early-stage Alzheimer's disease.Clinical trials showed that donanemab slowed Alzheimer's progression by 29% over 18 months.According to Lilly, Medicare will cover the treatment and amyloid PET scans for eligible patients.
The Food and Drug Administration (FDA) on Tuesday approved donanemab, Eli Lilly's monoclonal antibody drug for early-stage Alzheimer's disease. The approval comes less than a month after the drug gained unanimous backing from an FDA advisory committee. This new drug will be sold under the brand name Kisunla.
Like Leqembi—an FDA-approved drug for Alzheimer's made by Eisai and Biogen—Lilly's Kisunla may slow the progression of Alzheimer's symptoms. Aduhelm, also made by Biogen, was approved in 2021 but discontinued due to concerns over its efficacy, side effects, and high cost.
These three drugs all work in the same way: by removing amyloid plaque deposits from the brain, which may be one cause of Alzheimer's disease.
“This is real progress. Today's approval allows people more options and greater opportunity to have more time,” Joanne Pike, DrPH, Alzheimer's Association president and CEO, said in a press statement. “Having multiple treatment options is the kind of advancement we've all been waiting for—all of us who have been touched, even blindsided, by this difficult and devastating disease.”
In 2023, around 6.7 million Americans had Alzheimer's disease, according to one estimate. This number is projected to double to 13.9 million people by 2060. There is currently no cure for the disease.
Safety and Efficacy of Kisunla
The clinical trial to support Kisunla's application for approval included 1,736 patients between 60 and 85 years of age. Researchers found that Kisunla slowed the progression of Alzheimer's by 29% over 18 months, compared to a placebo.
In a meeting last month, an FDA advisory panel said that Lilly's new drug is effective at treating Alzheimer's patients at the early stages of the disease and that the benefits outweigh its risks.
During the trial, three patients taking Kisunla died after developing brain bleeding and swelling known as amyloid-related imaging abnormalities (ARIA). Several cases of ARIA occurred with both Aduhelm and Leqembi as well, which is why regular brain imaging is required for the drugs.
To reduce ARIA risks, Eli Lilly said it plans to ask patients to get a brain scan after the first infusion since most patients who had the condition did so in the first few weeks of the clinical trial.
Reisa Sperling, MD, a professor of neurology at Harvard Medical School who spoke at the FDA meeting, said it will be “important to minimize the risk of ARIA with careful monitoring and to have detailed discussions with patients and care partners regarding individual risk-benefit and allow patients and their care partners to make informed decisions for themselves and their loved ones,”
The FDA panelists noted that almost all of the trial participants were White, which means there's not much information on the effectiveness of the drug in other populations.
Who Is Eligible for Kisunla?
Kisunla is approved to treat people with mild cognitive impairment as well as people with mild dementia stage of early symptomatic Alzheimer's disease, if an amyloid PET scan confirms that they have amyloid buildup in the brain.
During the trial, Lilly required patients to stop taking Kisunla if their amyloid levels dropped below a certain level. The FDA advisory committee expressed concerns about the need for more follow-up testing and whether patients whose amyloid returned would again be eligible for the drug. However, the approval didn't specify how follow-up testing should be conducted.
How Is Kisunla Administered?
Like Leqembi and Aduhelm, Kisunla is given as an infusion at a clinic or hospital, which could be a barrier for some patients. Leqembi is given every two weeks, while Kisunla is given monthly.
Eisai and Biogen have recently submitted an application to the FDA for an autoinjector version of Leqembi to be used as a maintenance treatment following a certain number of infusions. Neuroimmune, the original developer of Aduhelm, also reacquired the rights to the drug from Eisai and Biogen last year and is also working on an injectable version of Aduhelm.
While Kisunla is not a cure for Alzheimer's disease, patient advocacy organizations and health experts welcome this drug as a pathway to developing better treatments.
“This can give hope to patients suffering from Alzheimer's and their families to have something new on the horizon to try,” Cathryn Ann Devons, MD, a geriatric medicine specialist at Phelps Hospital in Sleepy Hollow, NY, told Verywell last month.
How Much Does Kisunla Cost?
The price for each vial of Kisunla is $695.65. For a six-month treatment, Lilly estimates the total cost to be $12,522.
However, the total cost will vary based on when the patient completes treatment. In the trial, 69% of the participants completed treatment at 18 months, which could cost over $48,000.
According to Lilly, insurance coverage for Kisunla and amyloid PET scans are available for eligible patients on Medicare.
What This Means For You
The FDA approved Eli Lilly's Kisunla (donanemab) to treat early symptomatic Alzheimer's disease. Medicare is expected to cover the treatment for eligible patients.
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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