(Reuters) -The European Commission on Tuesday authorized the use of Eisai and Biogen’s drug to treat mild cognitive impairment in the early stages of Alzheimer’s disease, but with strict conditions.
The move makes Leqembi the first drug in the European Union to target an underlying cause of the fatal mind-wasting disease.
The authorization allows Leqembi’s usage to treat people who have only one or no copy of the ApoE4 gene and who have sticky clumps of a protein called amyloid beta in the brain.
The APOE4 gene is linked with an earlier onset of Alzheimer’s disease.
The European Union’s medicines regulator concluded that the drug’s benefits outweighed the risks in a particular population of patients and as long as measures are applied to minimize risks.
The regulator last month rejected Eli Lilly’s Alzheimer’s drug, saying the treatment’s ability to slow cognitive decline was not significant enough to outweigh the risk of serious brain swelling in patients.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shreya Biswas)
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