FDA clears new Alzheimer’s Drug Leqembi

(NYT) — 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 FDA’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.”