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FDA Approves New Alzheimer’s Treatment

In studies, the medication slowed cognitive decline in adults in the early stages of the disease 


spinner image scan of a brain that is showing signs of alzheimers disease
Alamy Stock Photo

The U.S. Food and Drug Administration (FDA) approved the once-monthly medication donanemab (brand name Kisunla) for the treatment of Alzheimer’s disease, a brain disorder that affects nearly 7 million older Americans.

The news comes weeks after an independent panel of FDA advisers reviewed the drug’s data and voted in favor of its approval. 

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Kisunla is the second fully approved disease-modifying medication that’s available for the treatment of Alzheimer’s disease. A similar drug, lecanemab (Leqembi), got FDA approval in July 2023. Before that, the only approved Alzheimer’s drugs were medications that help to alleviate some of the disease’s symptoms, not disrupt its course.

“Alzheimer’s disease is a devastating disease for the person diagnosed and their loved ones,” said Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “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.

Delaying dementia’s progression

Clinical trial results for Kisunla were presented at the 2023 Alzheimer’s Association International Conference and published in the peer-reviewed medical journal JAMA.

Researchers found that the medication slowed the loss of thinking and memory skills in people with early Alzheimer’s, with the greatest benefits seen among those in the earliest stages of the disease.

Kisunla also helped to remove a protein called amyloid from the brain, which is a defining feature of Alzheimer’s. In people with the disease, amyloid clumps together to form sticky plaques that disrupt normal cell function.

Experts say delaying the more severe stages of Alzheimer’s is not a cure but can help preserve a person’s level of functioning for longer. This can be particularly helpful for those who are still able to work, pay bills and engage with others, as is the case for many individuals with early Alzheimer’s.

“These benefits are real and meaningful, giving people more time to participate in daily life, remain independent and make future health care decisions,” Maria C. Carrillo, chief science officer for the Alzheimer’s Association, said in a 2023 statement when the clinical trial results were released.

Researchers leading the 18-month-long trial found that Alzheimer’s symptoms did not worsen after a year of treatment for nearly half of participants who received Kisunla, compared with 29 percent who received a placebo. The study results suggest that people may not need the treatment indefinitely; patients in the study were taken off the drug once a certain amount of amyloid was removed from the brain.

“It’s encouraging to see that some patients essentially enter remission, where they achieve full amyloid clearance with donanemab, with no resurgence in substantial plaque buildup for nearly four years,” Howard Fillit, M.D., cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said in a recent statement.

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How long that state of remission lasts and what it means for the progression of Alzheimer’s symptoms is unclear, said Lawrence Sterling Honig, M.D., a professor of neurology at Columbia University Irving Medical Center and a neurologist at NewYork-Presbyterian.

Expanding options for patients and physicians

Jagan Pillai, M.D., an Alzheimer’s expert at the Cleveland Clinic Lou Ruvo Center for Brain Health in Cleveland, called Kisunla’s approval “a huge impetus to the field.” Adding another Alzheimer’s medication to the mix is “exciting” for patients and their loved ones, he said, “mostly because it gives them a range of choices to pursue therapeutic options in this area.”

Although Leqembi and Kisunla are in the same drug class, “it's always good to have more than one choice,” Honig echoed.

Both anti-amyloid medications are administered by an IV infusion: Leqembi is given twice monthly, and Kisunla is administered once a month. (Leqembi’s manufacturer seeks FDA approval on an injectable form of the medication.)

Side effects reported in the Kisunla trial were similar to those seen with Leqembi, swelling and bleeding in the brain being the chief concerns.

Often these events are small, temporary and asymptomatic, but larger bleeds can occur and can be serious, even fatal. Three study participants died from these effects. “These are side effects that require MRI monitoring, for both drugs,” Honig said.

Kisunla’s maker, Eli Lilly, priced the drug at $32,000 a year, higher than Leqembi’s $26,500 annual list price, though costs will vary depending on how long someone takes the drug. Out-of-pocket expenses will depend on an individual’s insurance.

Medicare will cover Alzheimer’s treatments that are FDA-approved for people who meet certain criteria, including having confirmed presence of amyloid plaques. Patients are required to work with a health care provider who participates in a registry to collect information on the safety and effectiveness of the medication.

Despite many similarities, there are a handful of differences between Leqembi and Kisunla. Choosing which to take “is something that is for patients to discuss with their neurology practitioners,” Honig said.

It’s unclear when Kisunla will be widely available; Pillai and Honig predict the rollout will take a few to several months.

Search for Alzheimer’s treatments continues

Even after this latest medication approval, the search for effective Alzheimer’s treatments continues.

Hundreds of potential treatments are being studied, including by the AARP-backed Dementia Discovery Fund, and many have targets other than amyloid. The Cleveland Clinic’s Pillai said experimental therapies targeting tau, another hallmark of Alzheimer’s disease, are among the more exciting discoveries happening. “And there’s a lot of interest in targeting other changes going on,” he said.

“Alzheimer’s disease and related dementias are complex disorders, caused by a constellation of overlapping and intertwined chains of biochemical reactions that wreck the brain,” Richard J. Hodes, M.D., director of the National Institute on Aging, said in a statement. “Successfully treating each individual’s dementia will likely require a diverse set of preventative and diagnostic therapies. The data reported in these donanemab and lecanemab studies suggest that anti-amyloid therapies may, at least, be the first of many other treatments.”

Editor’s note: This story, first published July 18, 2023, has been updated to include new information.

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