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The European Commission—of the European Union (EU)—said Wednesday that it had given formal approval for Leqembi, a long-awaited new treatment for early-stage Alzheimer's disease, to be sold in the EU under strict conditions, AFP reports.
The authorization was granted Tuesday based on a favorable decision by Europe's medicines watchdog, which after initial misgivings endorsed the treatment last November for a set category of patients.
Leqembi, developed by US multinational Biogen and Japanese-based Eisai, is the brand name of an active substance called lecanemab that is used to treat adults with mild memory and cognitive problems resulting from the early stages of the common type of dementia.
The first such medicine to be allowed in the EU, the drug was approved in line with the "positive scientific assessment of the European Medicines Agency [(EMA)]," the commission said in a statement.
The EMA "concluded that the benefits of this medicine outweighed the risks, in a particular population of patients with such disease and as long as risk minimization measures are applied," the commission said. “Therefore, the authorization decision also sets strict conditions on the use of Leqembi, as well as clear risk mitigation requirements.”
The EMA endorsed the drug only for patients with a lower risk of potential brain bleeding: those who have "only one copy or no copy of ApoE4", a type of gene known as an important risk factor for Alzheimer's.