U.S. health advisers are backing the full approval of an Alzheimer's drug that received preliminary approval last year.
“For an illness like this where we don’t have very much, these are meaningful changes for patients with Alzheimer’s,” said Dr. Merit Cudkowicz of Harvard Medical School. “A couple more months in the highly functional state is really meaningful.”
But concerns about the cost and effectiveness of new plaque-targeting drugs like Leqembi have attracted new scrutiny to the process from academics, members of Congress and health insurers. Eli Lilly and Co. said Wednesday its experimental Alzheimer's drug appeared to slow worsening of the mind-robbing disease in a large study. NBC 5's Bianca Castro talked with Frisco neurologist Dr. Aimee Garza about how it works.
But last week she announced extra requirements even after Medicare coverage begins: All patients receiving the drug will need to be enrolled in a federal registry to track Leqembi's safety and effectiveness. That approach is occasionally used for complex new medical devices, but rarely for drugs. But most FDA panelists were impressed by Eisai's results, which they said showed significant differences in patients' cognitive abilities and function, as well as reduced burden for caregivers.
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