Experts in dementia have welcomed the latest milestone in treating Alzheimer’s disease after Eli Lilly published trial results showing that its new drug significantly reduced memory loss and cognitive degeneration.
The US Pharmaceuticals Group on Monday presented the full results of its phase 3-clinical study of donanemab to the Alzheimer’s Association International Conference, which was held in Amsterdam. It showed that the antibody treatment slowed the progression of disease by approximately 35 percent in the early stages.
Leqembi, a new antibody drug that has received full approval by the US Food and Drug Administration, was also approved for marketing this month.
Eli Lilly said on Monday that the FDA had approved donanemab and they expected to receive a decision by the end of the year. Other global regulators have also been contacted.
Experts in the field of dementia have called Lilly’s presentation on donanemab, published in the Journal of the American Medical Association a milestone in the field.
Richard Oakley is the associate director of research for the Alzheimer’s Society in the UK. “The last eight months have marked a turning point. Two drugs were shown to slow the progression of disease, after decades of working without positive results,” he said.
Donanemab was tested on 1,736 participants, aged 73 to 74 years old. Half received intravenous treatment while the other half received a placebo. The trial lasted 18 months. The drug was most effective in the early stages of the disease.
Oakley explained that both lecanemab (also known as donanemab) and donanemab, are based upon antibodies against amyloid. Amyloid is one of the toxic protein buildups in the brain when Alzheimer’s progresses. However, they work at different stages.
Lecanemab acts when amyloid begins to form in the brain, while donanemab works at a later time, after the fibres are clumped into larger plaque accumulations. Both drugs caused swelling and bleeding in the brain, but only a minority of patients experienced this. Oakley said that although the design of the clinical trials for the two drugs makes direct comparisons difficult there are some indications that lecanemab may be more effective when given to Alzheimer’s patients in the early stages.
The drug cleared the amyloid plaques from the brain of some participants who were then removed from the drug.
Howard Fillit of the Alzheimer’s Drug Discovery Foundation in the US says that lecanemab is also a potential benefit for donanemab because patients are given two-weekly infusions, compared to every week for donanemab.
Lilly has not yet set a price for Leqembi. Biogen and Eisai announced that the US list price would be $26,500 per year.
Fillit said that there will be some price competition with two drugs available on the market. However, he did not know which factors would play a major role in the marketplace.
Datamonitor Healthcare predicts that combined sales of the two products will reach $9bn per year in 2030 on the main world markets.
Fillit said, “This is an important moment in history but only the beginning.” “We need to continue to advance the drug pipeline in order to develop the next generation of drugs based on the biology behind ageing, to stop Alzheimer’s disease at its roots.”
He said that the future of medicine will be tailored drug combinations for each individual based on biomarker testing.