Pat Bishara, 79, a mother of three from Carmel, Indiana, had her final infusion on June 6. She joined the trial of Eli Lilly’s Alzheimer’s drug in mid-2021, three and a half years after being diagnosed with mild cognitive impairment in late 2017. On Tuesday, the Food and Drug Administration approved that drug.
Bishara took part in both the phase 3 trial and the extension trial that offered the drug to people first given a placebo. She said she had no noticeable side effects. She still sometimes has trouble remembering people’s names, but most people might not realize she has the disease. “I feel in my heart I wouldn’t be doing as well as I’m doing if I wouldn’t have been on something,” she said.
What the FDA cleared
The drug is donanemab, to be sold as Kisunla. Lilly said the FDA cleared it for adults with mild cognitive impairment or early Alzheimer’s disease. It is a monoclonal antibody infusion given every four weeks, and it works by targeting amyloid in the brain, considered a hallmark of the disease.
The approval rests on a late-stage trial of 1,700 people. After 18 months, the drug had slowed the progression of Alzheimer’s by about 35% compared with a placebo. Decline was measured on the clinical dementia rating scale, which scores memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The results were similar to those seen with Leqembi.
Lilly expects patients to be able to stop treatment once their amyloid reaches very low levels. Nobody knows yet whether or when it might return. If it does, a patient would most likely need to restart.
Risks
Kisunla carries potentially life-threatening side effects, as other drugs in its class do. They include brain swelling and brain bleeding. Most cases in the trial were mild, but the FDA said three deaths were linked to the drug.
The agency originally planned to rule in March. It delayed the decision to ask its advisory panel whether the benefits outweighed the side effects. Last month that committee of outside experts unanimously recommended approval.
Cost and coverage
Lilly said a 12-month supply will cost $32,000. Medicare is expected to cover it. The Centers for Medicare and Medicaid Services said last year it will pay for new Alzheimer’s drugs that win full FDA approval, though doctors must collect data on how the drugs perform in the real world.
Dr. Ronald Petersen, a neurologist at the Mayo Clinic, said the approval matters because it adds a treatment option for a devastating disease. “It will give clinicians and patients a choice,” he said.
Kisunla is the second drug of its kind approved, after Leqembi, which received full FDA approval last summer. A third, Biogen’s Aduhelm, was taken off the market this year. The Alzheimer’s Association estimates that 6.7 million people in the U.S. ages 65 and older were living with the disease last year, a number projected to reach 13.8 million by 2060.
