BREAKING: FDA approves Alzheimer’s drug shown in clinical trials to slow cognitive decline in patients in the early stages of the illness.
The FDA did not seek the advice of its advisory committee — which it did do before it controversially approved another Alzheimer’s drug developed by Biogen, called Aduhelm, in 2021.
Leqembi is not a cure; it aims to slow the progression of the disease by removing clumps of beta-amyloid —The benefit is small, experts say, but added anything that might give patients additional time with family and other loved ones is valuable.. The Centers for Medicare & Medicaid Services currently limits coverage of drugs that target amyloid in the brain, so uptake of the new medication may be limited at first, Ivan Cheung, the U.S. chairman and CEO of Eisai, told NBC News.
The Alzheimer's Association has said that based on the Eisai and Biogen phase 3 clinical trial results, the FDA should approve Leqembi for early-stage Alzheimer’s. The organization is urging the Centers for Medicare & Medicaid Services to revise its decision on new Alzheimer's treatments. Last year, in response to the poor data supporting Aduhelm's approval, the CMS said it wouldn’t cover Alzheimer’s drugs that target amyloid unless patients are in a clinical trial.
Making the drug more widely available could mean more patients have"many months more of recognizing their spouse, children and grandchildren," said Maria Carrillo, the chief science officer for the Alzheimer’s Association.
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