Experts on Wednesday welcomed preliminary data on a new Alzheimer’s drug that slowed cognitive decline, the first drug to achieve this goal.
Called Lecanemab, it was tested in a clinical trial of nearly 1,800 people and reduced cognitive decline by 27 percent over an 18-month period, according to early results announced by manufacturers Biogen and Eisai.
“It is the first drug that has been shown to not only clear the buildup of a protein called amyloid in the brain, but also have a small but statistically significant impact on cognitive decline in early-stage patients,” explained Susan Kohlhaas, from Alzheimer’s UK, a UK-based organization specializing in dementia research.
However, experts cautioned about the preliminary nature of the results, which were announced in a press release ahead of publication in a peer-reviewed journal, given that the companies aim to start marketing the treatment in January 2023 in the United States. Joined.
Biogen has already brought another Alzheimer’s drug called Aduhelm to market, but there was a lot of controversy over the evidence that it worked, and its approval led to three high-level resignations at the US Food and Drug Administration (FDA). acronym in English).
According to a statement from Biogen and Eisai, in addition to slowing cognitive decline, the new treatment also slowed the brain’s buildup of the protein amyloid, which forms sticky plaques and kills brain cells.
Side effects included higher rates of swelling and bleeding in the brain in the treatment group compared to people given a placebo.
Both the treatment and placebo groups had people with similar characteristics, including a wide range of underlying conditions. A quarter were Hispanic and African-American.
Michel Vounatsos, CEO of Biogen, stressed that if approved, the drug “will give patients and their families hope that the progression of the disease can potentially be delayed.”
Masud Husain, from the University of Oxford, in a statement, explained: “While the summary of results certainly looks very encouraging, we need to be cautious until we are allowed to review the data fully.
“It’s also important to note that the trial results apply only to people with mild Alzheimer’s disease, not everyone with the condition, and that there were significant side effects of the drug, including bleeding in the brain,” warned.
“The study results support the amyloid hypothesis that abnormal accumulation of AB in the brain is a major cause of Alzheimer’s, when targeted with protofibril-binding therapy. Eisai believes that these findings will create new horizons in the diagnosis and treatment of the disease, as well as trigger innovation for new therapy options,” said Haruo Naito, CEO of Eisai.
Shares of Biogen and other health companies studying Alzheimer’s rose on Wednesday after Japanese drugmaker Eisai said its experimental treatment appeared to slow the disease’s progress in a study.
Eisai said he would discuss the study results at a conference in late November. He also plans to publish his findings in a specialized medical journal.
The company is already seeking expedited approval from the FDA, which could issue its decision early next year.
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