Federal health authorities on Tuesday gave approval to an experimental new drug that has shown to delay the onset of Alzheimer’s disease in trials.
Donanemab, manufactured by Eli Lilly, is the second medication that has won the blessing of the Food and Drug Administration (FDA) to treat patients showing early symptoms of the disease, most prominently 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 addressing its symptoms, the FDA said.
Indianapolis-based Eli Lilly reported the success of its trial a year ago, and subsequently applied for the FDA authorization that was announced today. Experts at the time said it “could be the beginning of the end of Alzheimer’s disease”, which affects almost 7 million people, mostly older Americans, according to the Alzheimer’s Association.
“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options,” Anne White, executive vice-president of Eli Lilly said on Tuesday, referring to donanemab by the brand name it will be sold under.
“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 who took 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 excessive buildup of amyloid plaques and slow the decline that may diminish people’s ability to remember new information, important dates, and appointments; plan and organize; make meals; use household appliances; manage finances; and be left alone”, an Eli Lilly statement said.
Kisunla will be expensive, with each vial costing almost $700 and a year’s course expected to be $32,000, according to Lilly’s calculation. But the Centers for Medicare and Medicaid Services announced last year it planned to cover new Alzheimer’s drugs approved by the FDA, as long as physicians maintained a rigid record of their performance.
It also comes with some risk, the FDA said. Side effects include potential brain swelling or bleeding, but those were reportedly 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 the benefits outweighed any risk.
Side effects were similar to those reported in Leqembi.
“Diagnosing and treating Alzheimer’s sooner than we do today has the potential to meaningfully slow disease progression, giving patients invaluable time to maintain their independence for longer,” said Dr Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation, in the Lilly statement.
“This approval marks another step forward in evolving the standard of care for people living with Alzheimer’s disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer’s community.”