The Food and Drug Administration (“FDA”) announced they have fully approved the first drug shown to slow down Alzheimer’s disease. Leqembi, whose generic name is lecanemab, should be widely covered by the federal Medicare health insurance program, which primarily serves adults age 65 and older – meaning more people who are in the early stages of the disease will have access to the drug, and will be able to afford it.
Leqembi comes from the Japanese pharmaceutical company Eisai, and its U.S. partner Biogen. The companies have said Leqembi will cost about $26,500 a year. In studies reviewed by the FDA, Leqembi appeared to slow declines in memory and thinking by about 27% after 18 months of treatment. It also dramatically reduced the sticky beta-amyloid plaques that tend to build up in the brains of people with Alzheimer’s.
In January, the drug received what’s known as accelerated approval from the FDA, based on its ability to remove the substance beta-amyloid from the brains of people in the early stages of Alzheimer’s. Full or traditional approval reflects the FDA’s assessment that Leqembi also helps preserve memory and thinking. The Centers for Medicare and Medicaid Services announced in January it would broaden coverage of Leqembi on the same day the drug received full FDA approval. That should mean the drug will now be covered for most Medicare patients with early signs of cognitive problems and elevated levels of amyloid. Under the expanded coverage, a million or more Medicare patients are potential candidates for the drug. Leqembi requires an initial test to determine amyloid levels in the brain, intravenous infusions every other week, and periodic brain scans to detect side effects.
Dr . Sanjeev Vaishnavi, director of clinical research at the Penn Memory Center, said: “It’s not something that’s going to stop the disease or reverse it. But it may slow down progression of the disease and may give people more meaningful time with their families … It’s very exciting that we’re targeting the actual pathology of the disease.”
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