A new hope, in the fight against the disease ofAlzheimer. The authorization of a new drug developed by the pharmaceutical group Eli Lilly could take place this year in the United States, after the publication on Monday July 17 of the complete results of a large-scale clinical trial.
These confirmed the ability of the treatment, donanemab, to slow the progression of the disease in patients, especially when taken very early. But some experts remain cautious about this new treatment, whose benefits remain “modest” and which has potentially dangerous side effects.
The American Medicines Agency (FDA) approved in May a first similar treatment against Alzheimer’s, Leqembi (lecanemab molecule), developed by Eisai and Biogen. Eli Lilly said she expected a decision from the American health authorities “by the end of the year” and assured that she was in the process of filing her requests elsewhere in the world. Donanemab, like lecanemab, is given intravenously and attacks plaques in the brain of affected patients, called amyloid plaques.
Expert skepticism
The clinical trial for Eli Lilly’s treatment was conducted in eight countries on more than 1,700 people aged 60 to 85 who had not yet reached an advanced stage of the disease. The results were released on Monday in the scientific journal Jama.
For a subgroup of around 1,200 people whose brains showed lower levels of a protein called Tau – indicating an even earlier stage of the disease – treatment led to a reduction in cognitive and functional decline (ability perform daily activities) by 35% over 18 months.
But the treatment can lead to serious side effects, such as edema or cerebral hemorrhage. Three deaths of clinical trial participants are likely treatment-related, according to the study.
A step in the right direction
“The modest benefits would likely not be questioned by patients, clinicians, or taxpayers” if these treatments were “low risk, inexpensive, and simple to administer,” several experts said. in a commentary article also published in Jama. “But none of the three are proven.”
Collecting more data, including beyond 18 months, will be crucial to better understand the balance between the benefits and the risks of these drugs, they stressed. They also criticized the low proportion of people of color included in the trial, despite being more affected by the disease.
These “first generation” drugs are “not perfect”, summarized Susan Kohlhaas, of the organization Alzheimer’s Research UK. “But they are a big step in the right direction.” “They represent an important breakthrough that will pave the way for many future treatments,” said Giles Hardingham, professor of pharmacology at the University of Edinburgh.
With AFP
2023-07-17 21:49:50
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