Good news for Alzheimer’s care. The US FDA has granted the full approval to lecanemab for the treatment of Alzheimer’s disease. Trial data has shown that treatment slows the progression of the disease, the decline of memory and thinking, in 27% of patients after 18 months of treatment.
FURTHER INFORMATION
Today comes a full authorization from the Food and Drug Administration (Fda) of the United States. What is lecanemab? It is a monoclonal antibody. Following “a confirmatory study that verified the clinical benefit” of the antibody, the drug was granted traditional approval, explains the US regulatory body in a note. First antibody targeting amyloid-beta protein to be converted from accelerated approval to mainstream approval for the treatment of Alzheimer’s, specifies the FDA.
The drug works reducing amyloid plaques that are formed in the brain, a determining pathophysiological feature of the disease.
Alzheimer’s, the monoclonal antibody that slows down the disease (and reduces amyloid plaques)
This group* had been approved in January under the fast track (reserved for drugs for serious conditions where there is an unmet medical need), based on clinical data demonstrating the effect on the reduction of amyloid plaques in the brain, from which – the experts explain – it is reasonable to predict a clinical benefit for the patients. But the FDA has required the company to conduct a “confirmatory” clinical trial to verify the expected clinical benefit of the treatment. This efficacy was assessed using the results of ‘Study 301’ (Clarity Ad), a phase 3 randomized controlled clinical trial.
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“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s has shown clinical benefits in this devastating disease,” he said. Theresa Buracchio, acting director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
FDA has approved Leqembi, the first monoclonal antibody directed against amyloid plaques, for patients with Alzheimer’s disease.
— Stefano Berto, PhD (@StefanoBerto83) July 7, 2023
The side effects headaches, infusion-related reactions and imaging abnormalities related to amyloid (Aria), a side effect that occurs with the class of antibodies directed against amyloid. The use of anticoagulant drugs was associated with an increase in the number of intracerebral haemorrhages in patients taking lecanemab compared to placebo. The prescribing information therefore recommends caution when considering use of the drug in patients taking blood thinners or with other risk factors for intracerebral hemorrhage.
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The antibody it should be started, explains the FDA in the note, in patients with mild cognitive impairment or mild dementia stage of Alzheimer’s diseasei.e. the population in which the treatment was studied in clinical trials. US approval was granted to Eisai, who developed the drug with Biogen.