FDA approves second Alzheimer’s drug that may slow onset of disease | Alzheimer’s

Federal health authorities gave approval Tuesday to an experimental new drug that has been shown to delay the onset of Alzheimer’s disease in trials.

Donanemab, made by Eli Lilly, is the second drug to win Food and Drug Administration (FDA) approval to treat patients showing early symptoms of the disease, most notably cognitive impairment.

Last year, authorities cleared the drug lecanemab, marketed under the brand name Leqembi, after it demonstrated a similar reduction in Alzheimer’s progression in a control group.

The treatments are not a cure, but the first to physically alter the course of the disease rather than simply address its symptoms, the FDA said.

Indianapolis-based Eli Lilly reported the success of its trial a year ago, and then 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 showed very meaningful results for people with early symptomatic Alzheimer’s disease who urgently need effective treatment options,” Anne White, Eli Lilly’s executive vice president, said Tuesday, referring to the brand name donanemab. 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 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 received 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 amyloid protein deposits in the brain, a key indicator of the presence of Alzheimer’s.

The drug “can help the body remove excess amyloid plaque buildup and slow the decline that can reduce people’s ability to remember new information, important dates and appointments; plan and organize; make meals; use household appliances; manage finances; and leave you alone,” Eli Lilly said in a statement.

The drug will be expensive, with each bottle costing almost $700 and a year’s course expected to be $32,000, according to Lilly’s calculations. But the Centers for Medicare and Medicaid Services announced last year that it planned to cover new FDA-approved Alzheimer’s drugs as long as doctors kept a solid record of their performance.

It also comes with some risk, the FDA said. Side effects include possible brain swelling or bleeding, but they were reported 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 the benefits outweighed any risks.

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 precious time to maintain their independence for longer,” said Dr Howard Fillit, co-founder and chief science officer at the Foundation. of Alzheimer’s Drug Discovery. in Lilly’s statement.

“This approval marks another step forward in developing the standard of care for people living with Alzheimer’s disease, which will eventually include an arsenal of new treatments, providing much-needed hope to the Alzheimer’s community.”

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