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US medical advisers vote to recommend Eli Lilly Alzheimer drug
An independent panel of US medical experts voted Monday to recommend Eli Lilly's experimental Alzheimer's drug, meaning there could soon be another treatment option available to patients with the devastating brain disorder.
Donanemab was found in a trial carried out last year to slow cognitive decline in the early stages of the disease—but there was also a high rate of side effects, including deaths.
The Food and Drug Administration (FDA) in March pushed back a planned meeting of experts to evaluate the safety of the intravenously-injected antibody.
It normally follows its advisers' recommendations, but is not required to do so.
A green light would mean there is a second therapy that targets the underlying causes of Alzheimer's, the most common form of dementia that affects one in nine people over 65, progressively robbing them of their memories and independence.
In Alzheimer's disease, two key proteins, tau and amyloid beta, build up into tangles and plaques, known together as aggregates, which cause brain cells to die and lead to brain shrinkage.
If approved, donanemab will be the third drug targeting amyloid beta to hit the market. Biogen and Eisai launched the first, called Aduhelm, which was controversially approved in 2021 despite concerns over its effectiveness, and later withdrawn.
The same companies got another drug called Leqembi, which works in the same way, approved last year.
Panelists in Monday's meeting were asked to consider whether donanemab should be recommended widely, including among people with no or low levels of tau in their brain, who were not included in the trial study.
In explaining their votes, several said the need to gather more data to reduce scientific uncertainty should not prevent people from accessing and benefiting from the medication in the short term.
They also found the benefits of the treatment outweighed the risks of people in the early stages of the study, proposing ways to mitigate the risk of brain bleeds by monitoring patients with MRI.
Eli Lilly stock was up 1.8 percent at the close of trading at $865.
© 2024 AFP
