Title: Landmark Trial Results Show Eli Lilly’s New Drug Slows Memory Loss in Alzheimer’s Patients
Subtitle: Experts Declare Breakthrough in Dementia Treatment with Donanemab
Date: [Insert Date]
In a monumental breakthrough for the field of dementia research, Eli Lilly has released trial results demonstrating the significant slowing of memory loss and cognitive decline in Alzheimer’s patients. The findings were announced at the Alzheimer’s Association International Conference in Amsterdam, where the US pharmaceuticals group presented the full results of its phase 3 clinical study of donanemab.
This antibody treatment showcased promising results, indicating a 35% reduction in disease progression during the early stages of Alzheimer’s. Last November, similar phase 3 findings were released by US biotech company Biogen and Japan’s Eisai for their antibody drug lecanemab, now approved by the US Food and Drug Administration under the brand name Leqembi.
Eli Lilly revealed that it has submitted donanemab for FDA approval, expecting a decision before the year-end. The company is also pursuing submissions to other global regulatory bodies. Dementia experts hailed the donanemab trial findings as a landmark in the field, marking a significant turning point after decades of unsuccessful attempts to slow down the disease’s progression.
Richard Oakley, associate director of research at the UK charity the Alzheimer’s Society, described the past eight months as transformative in dementia research. Oakley stated, “Two drugs are shown to slow down the progression of the disease after decades of work with no positive findings.” The donanemab trial involved 1,736 participants aged 73 on average, all of whom exhibited mild to moderate Alzheimer’s symptoms. Half of the participants received intravenous infusions of the treatment, while the other half received a placebo every four weeks for a span of 18 months. The drug demonstrated its highest effectiveness in slowing disease progression during the earlier stages.
Donanemab and lecanemab are both antibody-based drugs targeting amyloid, one of the toxic proteins that accumulate as Alzheimer’s advances. However, they operate at different stages of the disease. Lecanemab targets amyloid as it begins to form fibers, whereas donanemab is effective at a later stage, targeting clumped-together fibers that form larger accumulations of plaque in the brain. The primary adverse side effect observed in a small minority of patients for both drugs was swelling and bleeding of the brain.
Although direct comparisons between the two drugs are challenging due to differences in clinical trial designs, there were tentative indications that donanemab may be more effective when administered to individuals in the earliest stages of Alzheimer’s. Remarkably, it completely cleared amyloid plaques from the brains of certain participants who were subsequently taken off the drug.
Howard Fillit, chief scientist at the US-based Alzheimer’s Drug Discovery Foundation, identified another potential advantage for donanemab, noting that lecanemab requires infusions twice as frequently, administered every two weeks. While Biogen and Eisai announced a US list price of $26,500 per year for Leqembi, Eli Lilly has not yet specified the pricing for its drug.
With both drugs expected to enter the market, competition in terms of pricing is anticipated. However, the exact factors that will determine market dynamics remain uncertain according to Fillit. Datamonitor Healthcare projects combined sales of both therapies to reach $9 billion annually by 2030 in the world’s primary markets.
Fillit emphasized that while these trial results represent a watershed moment, more progress is needed. He added, “We must continue advancing the drug pipeline to develop the next class centered around the biology of aging to ultimately stop Alzheimer’s in its tracks.” He further highlighted the potential of future therapies involving tailored drug combinations based on individual biomarker tests.
The latest breakthrough offers hope to millions affected by Alzheimer’s and signifies a significant step forward in the fight against dementia.