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 abilities in people with the disease, the drugmaker said Tuesday.
The drug donanemab, which will be sold under the brand name Kisunla, is a monoclonal antibody infusion given every four weeks.
The FDA cleared the drug for use in adults with mild cognitive impairment or early Alzheimer’s disease, the drugmaker said. Kisunla 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 granted full approval to a similar drug called Leqembi.
“It will give clinicians and patients a choice,” Petersen said.
An estimated 6.7 million Americans ages 65 and older were living with Alzheimer’s in 2023, according to the Alzheimer’s Association. The number is projected to increase to 13.8 million by 2060.
The agency’s approval was based on a late-stage clinical trial of 1,700 people that showed the drug slowed the progression of Alzheimer’s by about 35% after 18 months, compared to a placebo. Decline was measured using the clinical dementia rating scale, which focuses on how well patients performed in six categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
The results were comparable to those seen with Leqembi.
Once a patient’s amyloid has reached very low levels, Eli Lilly expects they would be allowed to stop taking the treatment, the company has said. It is not yet known if or when the amyloid might come back, but if it does, a patient would likely need to restart the 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 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 approved, behind Leqmebi. A third drug — Biogen’s Aduhelm — was taken off the market earlier this year.
Medicare likely to cover 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 a psychologist. She had her final infusion on June 6.
Bishara said she had no noticeable side effects during the trial. Although she sometimes has trouble remembering peoples’ names, she said, most people might not even realize she has the disease. She attributes that to the treatment.
“I feel in my heart I wouldn’t be doing as well as I’m doing if I wouldn’t have been on 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 will pay for new Alzheimer’s drugs that are granted full FDA approval, although it will require physicians to collect data about how well the drugs perform in the real world.
The FDA was initially set to decide about 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 the drug’s approval.