Federal health authorities on Tuesday approved an experimental new drug that has been shown to slow the onset of Alzheimer’s disease in trials.
Donanemab, manufactured by Eli Lilly, is the second medication to win the blessing of the Food and Drug Administration (FDA) to treat patients showing early symptoms of the disease, especially cognitive impairment.
Last year, authorities cleared the drug lecanemab, marketed under the brand name Leqembi, after it demonstrated a similar decline in the progression of Alzheimer’s in a control group.
The treatments are not a cure, but the first to physically alter the course of the disease rather than just address its symptoms, the FDA said.
Indianapolis-based Eli Lilly reported the success of his trial a year ago, and subsequently applied for the FDA authorization announced today. At the time, experts said it “could be the beginning of the end of Alzheimer’s disease,” which affects nearly 7 million people, mostly older Americans according to the Alzheimer’s Association.
“Kisunla has shown very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options,” Eli Lilly executive vice president Anne White said Tuesday, referring to the brand name donanemab under which it will be sold.
“We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis.”
According to Eli Lilly, Kisunla slowed cognitive and functional decline by up to 35% after 18 months, compared to patients taking a placebo. It also reduced participants’ risk of progressing to the next clinical stage of the disease by up to 39%, the company said.
Taken by infusion every four weeks, the monoclonal antibody works by targeting deposits of amyloid protein in the brain, a key indicator of the presence of Alzheimer’s.
The drug “can help the body remove the excess build-up of amyloid plaques and slow the decline that can reduce people’s ability to remember new information, important dates and appointments; plan and organize; making meals; use household appliances; manage finances; and be left alone,” an Eli Lilly statement said.
The drug will be expensive, with each vial costing nearly $700 and a year’s course expected to cost $32,000, according to Lilly’s calculation. But the Centers for Medicare and Medicaid Services announced last year that it plans to cover new Alzheimer’s drugs approved by the FDA as long as doctors keep a rigid record of their performance.
It also comes with some risk, the FDA said. Side effects include possible brain swelling or bleeding, but these were said to be mild in patients during the late-stage trial of 1,700 people. Three deaths were also attributed to the drug, but ultimately the FDA, which delayed approval in March for further evaluation, decided that the benefits outweighed any risk.
Side effects were similar to those reported in Leqembi.
“Diagnosing and treating Alzheimer’s earlier than we do today has the potential to significantly slow the progression of the disease, giving patients an invaluable opportunity to maintain their independence for longer,” said Dr. Howard Fillit, co-founder and chief scientist. officer at the Alzheimer’s Drug Discovery Foundation. in the Lilly statement.
“This approval is another step forward in developing the standard of care for people living with Alzheimer’s disease, which will ultimately include an arsenal of new treatments, providing much-needed hope to the Alzheimer’s community.”
