U.S. health advisers are backing the full approval of an Alzheimer's drug that received preliminary approval last year.
drug, a key step toward opening insurance coverage to U.S. seniors with early stages of the brain-robbing disease.
The FDA’s initial OK for Leqembi came via the agency’s accelerated approval program, which allows early access to drugs based on laboratory or biological measures suggesting that they might help patients. The drug, marketed by Eisai and Biogen, helped clear a brain plaque that is a hallmark of Alzheimer’s.
Normally the process of converting an accelerated approval attracts little attention, and FDA rarely convenes its advisers to weigh in on such decisions. Leqembi is priced similarly at $26,500 per year and the handful of patients who have received it to date have mainly had to pay out of pocket.
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