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The European Union’s drug regulator on Friday rejected a drug for the treatment of early Alzheimer’s disease from manufacturers Eisai and Biogen, saying the risk of potentially fatal brain swelling did not outweigh the drug’s small benefit in slowing cognitive decline, news.ro reported.
Experts at the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) have recommended against granting marketing authorization for Leqembi (lecanemab), a drug intended to treat Alzheimer’s disease. The committee concluded that the observed effect of treatment on slowing cognitive decline did not outweigh the risk of serious side effects associated with the drug, in particular the frequent occurrence of amyloid-related imaging abnormalities (ARIA), which include swelling of the brain and potential bleeding in patients receiving treatment. Manufacturers Eisai and Biogen said they would request a review of the recommendation. “We are very disappointed with the negative opinion of the CHMP and understand that it may also be disappointing to the wider Alzheimer’s community,” said Lynn Kramer, Eisai’s chief clinical officer. Lecanemab is the first drug shown to slow the progression of Alzheimer’s disease, has been fully licensed and reimbursed in the United States since July last year, and should also be the first drug in Europe to treat the neurodegenerative disease whose symptoms, Reuters reported.
The drug is an intravenous monoclonal antibody designed to remove amyloid deposits that have not yet aggregated into clumps. The infusion, given twice a month, clears the brain of sticky clumps of beta-amyloid, a protein considered a hallmark of Alzheimer’s disease. The EMA committee’s main concern related to imaging-enhanced amyloid abnormalities, a temporary brain swelling that is common with drugs that remove amyloid from the brain. “The severity of this side effect should be considered in the context of a minimal effect of the drug,” the regulator said. In clinical trials, the drug slowed cognitive decline by 27% in patients with early Alzheimer’s disease compared with a placebo. “We firmly believe that the data for lecanemab submitted to the CHMP clearly demonstrate its potential to slow the progression of Alzheimer’s disease,” said Priya Singhal, Biogen’s head of development. The committee’s recommendation must be formally supported by the European Commission, which typically follows decisions by regulatory experts. Alzheimer’s disease, the most common form of dementia, is a progressive neurodegenerative disorder estimated to affect more than 50 million people worldwide. In Europe, 7 million people suffer from the disease, which severely affects the brain, and that number is expected to double by 2050, according to the nonprofit Alzheimer’s Society Europe.
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