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The treatment of Alzheimer’s disease has reached a significant milestone with the release of trial results by Eli Lilly. The results show that their new drug, donanemab, effectively slows down memory loss and cognitive decline.
Eli Lilly presented the full findings of their phase 3 clinical study at the Alzheimer’s Association International Conference in Amsterdam. The study reveals that the antibody treatment reduced disease progression by around 35% in the early stages of Alzheimer’s.
This follows similar phase 3 findings from Biogen and Eisai, who released results for their antibody drug lecanemab and received full marketing approval from the US Food and Drug Administration under the name Leqembi.
Eli Lilly has submitted donanemab for FDA approval and expects a decision by the end of the year. Submissions to other global regulators are also being made.
Dementia experts have hailed the publication of Lilly’s donanemab presentation in the Journal of the American Medical Association as a landmark achievement.
“The past eight months have been a real turning point, as two drugs have been shown to slow down the progression of the disease after decades of work with no positive findings,” said Richard Oakley, associate director of research at the Alzheimer’s Society.
The donanemab trial involved 1,736 participants with mild to moderate symptoms of Alzheimer’s. The drug, administered through intravenous infusions, was compared to a placebo over 18 months. The treatment proved most effective in the earlier stages of the disease.
Both lecanemab and donanemab target amyloid, a toxic protein that accumulates in the brain during the progression of Alzheimer’s. However, they act at different stages of the process.
Lecanemab focuses on amyloid as it begins to form fibers, while donanemab is active at a later stage when the fibers have clumped together into larger plaque formations. The main adverse side effect of both drugs was brain swelling and bleeding, which only affected a small number of patients.
While direct comparisons between the two drugs are challenging due to different clinical trial designs, there are indications that donanemab may be more effective than lecanemab in the earliest stages of Alzheimer’s, according to Oakley. Donanemab completely cleared amyloid plaques from the brains of some participants, who were then taken off the drug.
Another potential advantage of donanemab, as pointed out by Howard Fillit, chief scientist at the US-based Alzheimer’s Drug Discovery Foundation, is that patients receive infusions twice as frequently as with lecanemab, every two weeks.
While Biogen and Eisai have announced a US list price of $26,500 a year for Leqembi, Lilly has not yet determined the price for donanemab.
“With two drugs on the market, we can expect some competition on price,” said Fillit, “but it is still unclear which factors will be influential in the marketplace.”
Datamonitor Healthcare predicts that the combined sales of both drugs will reach $9 billion per year by 2030 in the main global markets.
“This is a significant moment, but it is just the beginning,” added Fillit. “We must continue advancing the drug pipeline and develop the next class of drugs focused on the biology of aging to ultimately halt the progression of Alzheimer’s.”
He also emphasized that future therapies will likely involve tailored drug combinations based on individual biomarker tests.
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