The New York Times (7/6, Belluck) reports the FDA granted “full approval to the Alzheimer’s drug Leqembi (lecanemab), 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 agency’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.” However, the FDA “also added a so-called black-box warning…stating that in rare cases the drug can cause ‘serious and life-threatening events.’”
Reuters (7/6, Beasley, Steenhuysen) reports the drug, “which is given intravenously, has a U.S. list price of $26,500 per year.” The “new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies.” Additionally, “the drug’s new label includes data showing that the use of certain anti-coagulants with Leqembi has been linked to a risk of brain hemorrhage.”
Related Links:
— “New Federal Decisions Make Alzheimer’s Drug Leqembi Widely Accessible,”Pam Belluck, The New York Times , July 6, 2023