Eli Lilly drug slows progression of Alzheimer’s

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Dementia experts have hailed the latest milestone in Alzheimer’s treatment after Eli Lilly released trial results showing its new drug significantly slowed memory loss and cognitive decline.

The American pharmaceuticals conglomerate reported the full findings of its Phase 3 clinical study of donunumab at the Alzheimer’s Association International Conference in Amsterdam on Monday, which showed the antibody treatment slowed progression in the early stages of the disease by about 35 percent. Gave.

The peer-reviewed results follow similar Phase 3 findings released last November by US biotech Biogen and Japan’s Eisai for lecanumab, another antibody drug that received full approval from the US Food and Drug Administration this month under the Lekambi brand name. Marketing approval was received.

Eli Lilly announced Monday that it has submitted donanemab for FDA approval and expects a decision before the end of this year. Submissions to other global regulators are underway.

Dementia experts hailed Lilly’s donanemab presentation, published in the Journal of the American Medical Association, as a milestone in the field.

Richard Oakley, associate director of research at the UK charity Alzheimer’s Society, said: “The last eight months have been a real turning point, as two drugs slow the progression of the disease without any positive findings after decades of work.”

The donanumab trial involved 1,736 participants with an average age of 73 who had mild to moderate symptoms of Alzheimer’s, half of whom received intravenous infusions of the treatment and half received a placebo every four weeks for 18 months. The drug most effectively slowed the progression of the disease in the early stages.

Oakley said both lecanimab and donanumab are based on antibodies against amyloid, one of the toxic proteins that build up in the brain as Alzheimer’s progresses, but they worked at different stages of the process.

Lecanumab targets amyloid as it begins to form fibers in the brain while donanumab is active at a later stage, when the fibers clump together into larger accumulations of plaque. The main adverse side effect of both drugs was swelling and bleeding in the brain in a small number of patients.

Oakley said, although the clinical trial designs for both drugs make direct comparisons difficult, there were tentative indications that donanumab may be more effective than lecanumab when given to people in the early stages of Alzheimer’s.

It completely cleared amyloid plaques from the brains of some participants, who were then taken off the drug.

According to Howard Fillitt, chief scientist at the US-based Alzheimer’s Drug Discovery Foundation, another potential advantage of donamumab is that patients receive twice as frequent infusions for lecanumab — every two weeks.

While Biogen and Eisai have announced a US list price of $26,500 per year for Lekembi, Lilly said it is not yet ready to set a price for its drug.

“With two drugs on the market, we can expect some competition on price, but we don’t yet know which factors will play a significant role in the market,” Filitt said.

Datamonitor Healthcare projects combined sales of both products at $9 billion per year by 2030 in the world’s core markets.

“This is an important moment but it is just a beginning,” Filit said. “We must continue to advance the drug pipeline to develop the next class of drugs centered around the biology of aging to ultimately prevent Alzheimer’s.”

He said the therapy of the future would be drug combinations tailored to each individual through biomarker tests.