The Food and Drug Administration granted full approval to the Alzheimer’s medication, Leqembi, on Thursday, thereby enabling Medicare and other insurance plans to start covering the treatment for individuals with Alzheimer’s disease. This IV drug, developed by the Japanese pharmaceutical firm Eisai, has been proven to moderately slow cognitive decline in early Alzheimer’s patients. Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, confirmed that Leqembi’s successful clinical study validated its efficacy in managing Alzheimer’s.
Eisai had initially received conditional approval from the FDA in January based on preliminary results indicating that Leqembi worked by eradicating a brain plaque associated with Alzheimer’s disease. The full approval followed a review of data from a larger study involving 1,800 patients, in which Leqembi demonstrated a slowing of memory and thinking decline by about five months compared to a placebo. However, the prescribing information will include a severe warning about potential side effects such as brain swelling and bleeding.
This full FDA approval comes as a significant relief to Alzheimer’s patients and advocates who have been lobbying for Medicare to cover Leqembi. Concerns were raised about the financial strain on Medicare due to the cost of plaque-targeting drugs like Leqembi, which is priced at around $26,500 per annum. Medicare administrator, Chiquita Brooks-LaSure, clarified that the program would immediately begin paying for the drug, but recipients must be enrolled in a federal registry to monitor its safety and effectiveness in real-world use.
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