January 6, 2023
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The FDA has accelerated approval of Leqembi for the treatment of Alzheimer’s disease, making it the second approved treatment for Alzheimer’s disease, the FDA said in a press release.
Approval is subject to review of Phase 3 data. New England Journal of Medicine The results showed that Leqembi (lecanemab-irmb, Eisai) reduced amyloid markers in early AD and was associated with less cognitive and functional decline.
“This treatment option is the latest treatment to not only treat the symptoms of Alzheimer’s disease, but to target and influence the underlying disease processes of Alzheimer’s disease.” Billy Dunn, M.D., The director of the Division of Neuroscience at the FDA’s Center for Drug Evaluation and Research said in a release.
Leqembi was approved under the accelerated pathway used by the FDA to approve drugs for serious conditions when there is an unmet medical need. The agency said Alzheimer’s disease affects her more than 6.5 million Americans.
“This is encouraging news, but the approval of lecanemab is only the first step.” Howard Filitt, M.D., The Chief Scientific Officer of the Alzheimer’s Drug Discovery Foundation said in a foundation press release: “Therapies for Alzheimer’s disease will only benefit patients if the right drug is given to the right patient at the right time, based on their unique pathology. Is required.”
The prescribing information for Leqembi contains warnings about amyloid-associated imaging abnormalities (ARIAs) known to occur with this class of antibody, the FDA release said. ARIA is usually asymptomatic, but serious and life-threatening events are rare.
Additional warnings include the risk of infusion-related reactions, with symptoms such as flu-like symptoms, nausea, vomiting and changes in blood pressure.
Leqembi’s label says treatment for AD is indicated and should be initiated in people with mild cognitive impairment or mild dementia. In addition, the label states that there are no safety or efficacy data regarding initiation of treatment in early or late stages of disease.
“By taking it in the early stages of Alzheimer’s disease and slowing the progression of the disease, individuals have more time to participate in their daily lives and live independently,” said Alzheimer’s Association president and CEO. says. Joan Pike, DrPH, said in a release from the association. “This could mean many more months to recognize spouses, children and grandchildren. It could also mean more time for a person to drive safely.” there is [and] Manage your household finances accurately and quickly, participate fully in your hobbies and interests. “