The US FDA has approved a drug that appears to slow the onset of Alzheimer’s symptoms in the early stages of the disease. Soon also in Europe.
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It has just been approved by Food and Drug Administration (FDA) American. And soon it will also arrive in Europe, with a load of hope: the Lecanemab is a new drug for Alzheimer’s which, in clinical trials, has been shown to be able to slow cognitive decline in patients in the early stages of the disease. The drug, which will be sold under the name Leqembiis an infusion of monoclonal antibodies to be given every two weeks and has been validated in a fast track, which allows for the early approval of new drugs that “they serve an unmet medical need“.
The manufacturers will now have to conduct further clinical studies to confirm the benefits of the drug or risk removal from the market. But FDA approval, not a given, offers hope after repeated failures to find effective treatments. “This treatment option is the latest therapy to target and influence the pathological process underlying Alzheimer’s, rather than just treating the symptoms of the disease,” the statement reads. Leqembi is expected to be in the attention of European regulators starting in March.
New drug for Alzheimer’s: the study
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In late September, Eisai and Biogen, the companies that developed Leqembi, announced that according to a Phase 3 clinical trial of 1,795 patients, the drug would slow cognitive decline in people by 27 percent after 18 months.
Far from being a cure, the drug aims to slow the progression of the disease removing clumps of amyloid-beta from the brain, long thought by scientists to be a major cause of disease. A small advantage, according to the experts, but a precious one because it would allow patients to be given more time to be with their loved ones.
He waited for them
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Before claiming victory, Leqembi must in any case overcome the obstacle of side effects, which are not negligible: according to data from the phase 3 study, approximately 12.6% of patients who received the drug experienced cerebral edema, compared to just 1.7% of those in the placebo group. And at least 3 deaths appear to be linked to the drug, after patients experienced brain swelling or hemorrhaging. The manufacturer denied this, but in a report published in the New England Journal of Medicine, in any case reiterated the need “for longer studies to determine the efficacy and safety of the drug in the case of early Alzheimer’s”. And in the drug package insert, possible serious adverse effects such as edema and cerebral hemorrhage are reported, especially for those who use blood-thinning drugs.
Another limitation concerns the effects of Leqembi over time: experts say the drug won’t stop the disease, but it could delay the rate of progression. Also for this reason it has been approved only for patients with mild cognitive decline or who are in the early stages of Alzheimer’s. But Ivan Cheung, CEO of Eisai, is still “confident” about the benefits of the drug: “The disease is devastating – he explains – and causes great emotional turmoil for all the families involved”.
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