FDA Approves Second Alzheimer’s Drug That May Delay Disease Onset
Federal health authorities on Tuesday approved an experimental new drug that has been shown in trials to delay the onset of Alzheimer’s disease.
Donanemab, produced by Eli Lilly, is the second drug to receive Food and Drug Administration (FDA) approval for the treatment of patients with early symptoms of the disease, particularly cognitive impairment.
Last year, authorities approved the drug lecanemab, marketed under the brand name Leqembi, after it showed a similar reduction in Alzheimer’s progression in a control group.
According to the FDA, the treatments are not cures, but are the first to physically change the course of the disease rather than just address the symptoms.
Indianapolis-based Eli Lilly reported success in its trial a year ago and subsequently filed for FDA authorization announced today. Experts said at the time that it “could be the beginning of the end for 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,” Anne White, executive vice president of Eli Lilly, said Tuesday, referring to donanemab by the brand name under which it will be sold.
“We know that these drugs have the greatest potential benefit when people are treated earlier in their disease, and we are working hard 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 with 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.
The monoclonal antibody is administered through an IV every four weeks and targets deposits of amyloid proteins in the brain, a key indicator of the presence of Alzheimer’s.
The drug “may help the body clear the excess buildup of amyloid plaques and slow the decline that can reduce people’s ability to remember new information, important dates and appointments; plan and organize; prepare meals; use household appliances; manage finances; and be left alone,” according to a Statement from Eli Lilly said.
The drug will be expensive, with each vial costing nearly $700 and an annual course of treatment expected to cost $32,000, according to Lilly’s calculations. But the Centers for Medicare and Medicaid Services announced last year that it planned to cover the cost of new Alzheimer’s drugs approved by the FDA, as long as doctors kept strict records of their performance.
It also comes with some risks, the FDA said. Side effects include possible swelling or bleeding in the brain, 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 review, decided that the benefits outweighed any risks.
The side effects were similar to those of Leqembi.
“If we diagnose and treat Alzheimer’s earlier than we do now, we could significantly slow the progression of the disease, giving patients valuable time to remain independent for longer,” Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said in the Lilly statement.
“This approval marks another step forward in the development of the standard of care for people with Alzheimer’s disease, which will eventually include an arsenal of new treatments that will provide much-needed hope to the Alzheimer’s community.”