The authorization of an Alzheimer’s drug developed by the pharmaceutical group Eli Lilly could take place this year in the United States, after the publication Monday of the complete results of a large clinical trial.
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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 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.
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 published 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 to carrying out 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.
“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,” said Susan Kohlhaas of 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.
2023-07-17 18:37:11
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