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, Lilly 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 a full a pproval to a similar drug called Leqembi .

“It will give clinicians and patients a choice,” Petersen said.

An estimated 6.7 million people in the U.S. ages 65 and older were living with Alzheimer’s last year, according to the Alzheimer’s Association . The number is projected to increase to 13.8 million by 2060. Kisunla. (Eli Lilly) 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 similar to those seen with Leqembi .

Once patients’ amyloid has reached very low levels, Eli Lilly expects they would be allowed to stop taking the treatment, it has said. It is not yet known whether or when the amyloid might come back, but if it does, a patient would most 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 the second Alzheimer’s drug of its kind approved, […]

FDA approves new Alzheimer’s treatment that slows decline in memory