By MATTHEW PERRONE WASHINGTON — A closely watched won the backing of federal health advisers on Monday, setting the stage for the treatment’s expected approval for people with mild dementia caused by the brain-robbing disease. Food and Drug Administration advisers voted unanimously that the drug’s ability to modestly slow the disease outweighs its risks, including side effects like brain swelling and bleeding that will have to be monitored. “I thought the evidence was very strong in the trial showing the effectiveness of the drug,” said panel member Dean Follmann, a National Institutes of Health statistician.
The FDA will make the final decision on approval later this year. If the agency agrees with the panel’s recommendation, the drug, donanemab, would only be the second Alzheimer’s drug cleared in the U.S.
shown to convincingly slow cognitive decline and memory problems due to Alzheimer’s. The FDA approved a similar infused drug, . Lilly studied its drug by grouping patients based on their levels of a brain protein, called tau, that predicts severity of cognitive problems.
That prompted FDA reviewers to question whether patients might need to be screened via brain scans for tau before getting the drug. But most panelists thought there was enough evidence of the drug’s benefit to prescribe it broadly, without screening for the protein. “Imposing a requirement for tau imaging is not necessary and would raise serious practical and access concerns to the tre.