FDA approves Eli Lilly Alzheimer's drug, expanding treatment options in U.S.

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Donanemab will compete head-to-head with another treatment from Biogen and its Japanese partner Eisai called Leqembi

The Food and Drug Administration approved Eli Lilly's Alzheimer's drug donanemab, expanding the limited treatment options for the mind-wasting disease. Donanemab and a similar treatment called Leqembi from Biogen and Eisai are milestones in the treatment of Alzheimer's after three decades of failed efforts to develop medicines that can fight the fatal disease. for adults over 65, according to the Alzheimer's Association.

It's a long-awaited win for Eli Lilly after donanemab faced obstacles in its path to market. The FDA rejected the drug's approval last year due to insufficient data, then surprisinglyEli Lilly's drug is now the third of its kind to reach the market after Leqembi and an ill-fated therapy from Biogen and Eisai called Aduhelm. The two companies recently dropped that medicine.

Donanemab and Leqembi are milestones in the treatment of Alzheimer's after three decades of failed efforts to develop medicines that can fight the fatal disease. Both drugs are monoclonal antibodies that target toxic plaques in the brain called amyloid, a hallmark of Alzheimer's, to slow the progression of the disease in patients at the early stages of it. Neither treatment is a cure.

Three patients who took Eli Lilly's drug in a late-stage trial died from severe forms of those side effects, called amyloid-related imaging abnormalities, or ARIA.Pfizer struggles to regain faith with Wall Street, employees after Covid decline

 

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