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A new, breakthrough drug designed to aggressively treat Alzheimer’s disease was awarded accelerated approval by the Food and Drug Administration on Friday.
Leqembi — developed by Tokyo-headquartered Eisai — has been shown in trials to slow the cognitive and functional decline of people in the early stages of the illness. The accelerated approval comes amid concerns about the safety and the cost of the drug, previously known as lecanemab.
Massachusetts-based Biogen and Eisai will market the medication, which is a monoclonal antibody infusion every two weeks. It’s approved for use in patients with mild cognitive impairment or in the mild dementia stage of the disease.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Dr.