The Food and Drug Administration has approved a new Alzheimer’s medication from pharmaceutical company Eli Lilly, which is formally known as donanemab but will be sold and marketed under the brand name Kisunla.
Kisunla is a monoclonal antibody infusion given every four weeks, and works by targeting amyloid in the brain, which is considered a hallmark of Alzheimer’s disease. The drug has been shown in clinical trials to modestly slow a decline in memory and cognitive abilities in people with the disease, Eli Lilly reported on Tuesday.
According to the Alzheimer’s Association, an estimated 6.7 million people in the U.S. ages 65 and older were living with Alzheimer’s last year. This number is projected to increase to 13.8 million by 2060.
The FDA’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. The decline was measured using the clinical dementia rating scale, focusing on six categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
Results of the trial were similar to those seen with Leqembi, which is another drug used to slow the progression of Alzheimer’s disease that became FDA approved last summer.
The agency has now cleared Kisunla for use in adults with mild cognitive impairment or early Alzheimer’s disease, according to Eli Lilly. Dr. Ronald Peterson, a neurologist at the Mayo Clinic, told NBC News the approval is significant because it “will give clinicians and patients a choice” regarding treatment.
Similar to other drugs in its class, Kisunla also comes with potentially life-threatening side effects, including brain swelling and brain bleeding. While most cases identified in the trial were mild, three deaths were linked to the drug, the FDA reported.
The agency was initially set to decide about the treatment in March but delayed the decision to receive more guidance from its advisory panel on whether the benefits outweighed the side effects. Last month however, its committee of outside experts unanimously recommended Kisunla’s approval.
Eli Lilly said Kisunla will cost $32,000 for a 12-month supply. Medicare is expected to provide coverage for the drug, as last year, the Centers for Medicare and Medicaid Services said it will pay for new Alzheimer’s drugs that were granted full FDA approval. However, it will require physicians to collect data on how well the drugs perform for patients.
