The Food and Drug Administration approved a new Alzheimer’s drug from Eli Lilly that has been shown in clinical trials to modestly slow a decline in memory and thinking skills in people with the disease, the drugmaker said Tuesday.
The drug donanemab, which will be sold under the brand name Kisunla, is an infusion of the monoclonal antibody given every four weeks.
The FDA has cleared the drug for use in adults with mild cognitive impairment or early Alzheimer’s disease, the drugmaker said. Kisunla it works by targeting amyloid in the brain, considered a hallmark of Alzheimer’s disease.
The approval is significant because it adds another treatment option for the devastating disease, said Dr. Ronald Petersen, a neurologist at the Mayo Clinic. Last summer, the FDA gave full approval to a similar drug called Leqembi.
“This will give clinicians and patients a choice,” Petersen said.
About 6.7 million Americans age 65 and older were living with Alzheimer’s in 2023, according to the Alzheimer’s Association. The number is projected to grow to 13.8 million by 2060.
The agency’s approval was based on a late-stage clinical trial with 1,700 people that showed the drug slowed the progression of Alzheimer’s by about 35% after 18 months, compared with a placebo. Decline was measured using the Clinical Dementia Rating Scale, which focuses on patients’ performance in six categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
The results were comparable to those of Leqembi.
Once a patient’s amyloid has reached very low levels, Eli Lilly expects they will be allowed to stop treatment, the company said. It is not yet known if or when the amyloid can reverse, but if it does, the patient will likely need to restart treatment.
Like other drugs in its class, Kisunla also comes with potentially life-threatening side effects, which include brain swelling and brain bleeding. Although most of the cases identified in the trial were mild, three deaths were linked to the drug, according to the FDA.
Kisunla is now the second Alzheimer’s drug of its kind to be approved, after Leqmeb. A third drug — Biogen’s Aduhelm — was pulled from the market earlier this year.
Medicare will likely cover the treatment
Pat Bishara, a 79-year-old mother of three from Carmel, Indiana, participated in both the phase 3 trial and the extension trial, which offered Kisunla to those initially given a placebo.
She was diagnosed with mild cognitive impairment in late 2017 and joined the trial in mid-2021.
Along with the monthly infusion, Bishara was also regularly evaluated by the psychologist. She received her last infusion on June 6.
Bishara said there were no apparent side effects during the trial. Although she sometimes has trouble remembering people’s names, she said, most people may not realize she has the disease. She attributes this to the treatment.
“I feel in my heart that I wouldn’t be doing as well as I was doing if I hadn’t been in something,” Bishara said.
Lilly said Kisunla will cost $32,000 for a 12-month supply.
Medicare is expected to provide coverage for the drug. Last year, the Centers for Medicare and Medicaid Services said it would pay for new Alzheimer’s drugs that are given full FDA approval, though it will require doctors to gather data on how well the drugs work in real-world settings. real.
The FDA was originally set to rule on the treatment in March, but delayed the decision in order to get more guidance from its advisory panel on whether the benefits outweighed the side effects.
Last month, the agency’s committee of outside experts unanimously recommended approval of the drug.