An Alzheimer's drug won the backing of federal health advisers on Monday, setting the stage for the caused by thebrain-degenerating disease. A panel of Food and Drug Administration advisers unanimously agreed that the benefits of the Eli Lilly drug in slightly slowing down the disease outweigh its risks, which include side effects like brain swelling and bleeding that will need to be tracked. "I thought the evidence was very strong in the trial showing the effectiveness of the ," said panel member Dean Follmann, a statistician from the National Institutes of Health.
The will make the final decision on approval later this year. If the agency concurs with the panel's recommendation, the drug, donanemab, would only be the second Alzheimer's approved in the US that convincingly slows cognitive decline and memory issues due to . The FDA approved a similar infused drug, Leqembi, from Japanese pharmaceutical company Eisai last year.
In a separate vote, the FDA advisers unanimously agreed that the Lilly drug demonstrated effectiveness in various patient subgroups. Lilly's research on its drug involved categorizing patients by their levels of a brain protein called tau, which is indicative of the severity of cognitive issues. This led reviewers to debate whether patients should undergo brain scans for tau before receiving the medication.
However, most panelists believed the evidence of the drug's effectiveness was sufficient to prescribe it widely without tau screening. "Imposing a re.
