FDA approves second Alzheimer’s drug available in US after showing effectiveness for memory loss

NBC News

The U.S. Food and Drug Administration (FDA) on Tuesday approved a new Alzheimer’s drug from Eli Lilly that, according to clinical trials, moderately slows the decline in memory and cognitive ability in people with the disease, the pharmaceutical company reported.

The drug donanemab, which will be marketed under the brand name Kisunla, is a monoclonal antibody that is administered by infusion every four weeks.

The FDA has approved Kisunla for use in adults with mild cognitive impairment or early-onset Alzheimer’s disease. Kisunla targets brain amyloid, which is considered a hallmark of Alzheimer’s disease.

According to Mayo Clinic neurologist Dr. Ronald Petersen, the approval is important because it adds another treatment option for this devastating disease.

Last summer, the FDA granted full approval to a similar drug called Leqembi.

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

An estimated 6.7 million Americans age 65 and older were living with Alzheimer’s in 2023, according to the Alzheimer’s Association. That number is projected to rise to 13.8 million by 2060.

The agency’s approval was based on a late-stage clinical trial involving 1,700 people that showed the drug slowed disease progression by about 35 percent after 18 months, compared with a placebo.

Decline was measured with the Clinical Dementia Scale, which assesses patients’ performance in six categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and self-care.

The results were comparable to those obtained with Leqembi.

Once a patient’s amyloid has reached very low levels, Eli Lilly expects that the patient will be allowed to stop taking the treatment, the company has said. It is not yet known if or when the amyloid can recur, but if it does, the patient will likely have to restart the treatment.

Kisunla is now the second Alzheimer’s drug of its kind to be approved, following Leqmebi. A third drug, Aduhelm, from pharmaceutical company Biogen, was withdrawn from the market earlier this year.

Medicare will likely cover it

The drugmaker has not yet said how much Kisunla will cost, but it is expected to be priced in the tens of thousands of dollars a year.

Medicare is expected to cover the drug. Last year, the Centers for Medicare and Medicaid Services said it will pay for new Alzheimer’s drugs that win full FDA approval, though it will require doctors to collect data on their real-world effectiveness.

The FDA was originally scheduled to rule on the treatment in March but delayed the decision 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.