FDA approves Eli Lilly's Alzheimer's drug that can modestly slow disease

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WASHINGTON - U.S. officials have approved an Alzheimer's drug that can modestly slow the disease and a decline in memory, providing a new option to patients suffering from the memory-destroying ailment.

The Food and Drug Administration approved Eli Lilly’s Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer’s. It’s only the second drug that’s been convincingly shown to delay cognitive decline in patients, following last year’s full approval of a similar drug called Leqembi from Japanese drugmaker Eisai.

The drug, also called donanemab, which will be sold under the brand name Kisunla, is a monoclonal antibody infusion given every four weeks. Only those with early or mild disease will be eligible for the new drug, and an even smaller subset are likely to undergo the multi-step process needed to get a prescription.

Lilly’s results were similar to those of Leqembi, with both drugs showing modest cognitive improvement in early-stage Alzheimer’s patients. In a 1,700-patient study, Lilly found that patients receiving monthly IV infusions of donanemab declined about 35% more slowly than those on a placebo.

A sign with the company logo sits outside of the headquarters campus of Eli Lilly and Company on March 17, 2024 in Indianapolis, Indiana. (Credit: Scott Olson/Getty Images)

Physicians who treat Alzheimer’s say the approval is an important step after decades of failed experimental treatments.

Eli Lilly's Alzheimer's drug modestly slows disease

"I’m thrilled to have different options to help my patients," Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis, told The Associated Press. "It’s been difficult as a dementia specialist — I diagnose my patients with Alzheimer’s and then every year I see them get worse and they progress until they die."

The delay seen with both drugs amounts to a matter of months — about seven months, in the case of Lilly’s drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling.

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Alzheimer’s disease attacks brain regions responsible for wakefulness during the day, the researchers found, adding that wakefulness-promoting neurons in these regions are among the first to be damaged by the disease.

The highly anticipated Alzheimer's drug received support from federal health advisers last month, setting the stage for its likely approval.

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"I thought the evidence was very strong in the trial showing the effectiveness of the drug," said Dean Follmann, a statistician from the National Institutes of Health, to the Associated Press.

Cost of Alzheimer's drug

Costs will vary by patient, based on how long they take the drug, Lilly said. The company also said a year’s worth of therapy would cost $32,000 — higher than the $26,500 price of a year’s worth of Leqembi.

An estimated 6.7 million Americans have Alzheimer’s, according to the Alzheimer’s Association. They said this number could grow to 13.8 million by 2060 barring the development of medical breakthroughs to prevent, slow or cure the disease.

This story was reported from Los Angeles. The Associated Press contributed.