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The Food and Drug Administration on Thursday gave full approval to the Alzheimer’s drug Leqembi, and Medicare said it would cover much of its high cost, laying the foundation for widespread use of a medication that can modestly slow cognitive decline in the early stages of the disease but also carries significant safety risks. The F.D.A.’s decision marks the first time in two decades that a drug for Alzheimer’s has received full approval, meaning that the agency concluded there is solid evidence of potential benefit. But the agency also added a so-called black-box warning — the most urgent level — on the drug’s label, stating that in rare cases the drug can cause “serious and life-threatening events” and that there have been cases of brain bleeding, “some of which have been fatal.” (Belluck, 7/6)

To be eligible for Leqembi, someone must be in the early stages of the disease, marked by mild cognitive impairment and a buildup of the amyloid protein in the brain – the latter of which can be determined with a PET scan or spinal fluid test. The amyloid protein, along with the tau protein, are found in clumps and tangles in the brains of people with Alzheimer’s; Leqembi reduces amyloid buildup. An estimated 6 million Americans live with Alzheimer’s, and Leqembi could be an option for roughly 250,000 to 500,000 of them, said Dr. Gil Rabinovici, director of UCSF Alzheimer’s Disease Research Center. (Ho, 7/6)

The FDA recommends on Leqembi's label that doctors conduct testing for a gene called APOE4 that is associated with a higher risk of Alzheimer's as well as brain swelling associated with amyloid-lowering drugs. The FDA included a "boxed warning" that flags the risk of brain swelling on the label. The agency does not require APOE4 genetic testing and doctors and patients will need to weigh the risk of brain swelling against the drug's potential benefits. (Beasley, 7/6)

Leqembi is not a cure for Alzheimer’s, and the drug doesn’t improve patients’ memories or cognitive abilities. It also does not stop the disease from getting worse. What Leqembi can do is modestly slow down cognitive decline in patients who are in the early stages of the disease. Data from a large clinical trial suggested that the drug may slow decline by about five months over a period of 18 months for those patients. How the drug might affect a patient’s daily life is likely to vary widely. (Belluck, 7/6)