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FDA approves Alzheimer’s drug that slowed cognitive decline in clinical trial



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MRI image of brain showing area of Alzheimer patient.Getty ImagesThe Food and Drug Administration on Friday granted accelerated approval for the Alzheimer’s drug lecanemab, the second treatment from Biogen and its Japanese partner Eisai to receive an early green light in less than two years.The FDA’s approval comes after clinical trial results published in November indicated that lecanemab slows cognitive decline somewhat in people with mild impairment due to Alzheimer’s disease, but the treatment also carries risks of brain swelling and bleeding.Eisai, which led the development of lecanemab, is pricing the treatment at $26,500 per year in the U.S. It will be sold under the name Leqembi. The FDA can accelerate approval of a drug to quickly bring it to market if it’s expected to help patients suffering from serious conditions more than what is currently available. Biogen and Eisai applied for accelerated approval in July.”Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Dr. Billy Dunn, director of the FDA’s neuroscience division, in a statement. “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.”More than 6.5 million people in the U.S. suffer from Alzheimer’s. The irreversible disease destroys memory, thinking skills, …

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