Lilly’s Alzheimer’s Drug Wins Federal Advisers’ Backing for Approval, US

A closely watched Alzheimer’s drug from Eli Lilly 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 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, donanemab would be the second Alzheimer’s drug cleared in the US that’s been shown to convincingly slow cognitive decline and memory problems due to Alzheimer’s. The FDA approved a similar infused drug, Leqembi, from Japanese drugmaker Eisai last year. The slowdown seen with both drugs amounts to several months, and experts disagree on whether patients or their loved ones will be able to detect the difference. But Lilly’s approach to studying its once-a-month treatment prompted questions from FDA reviewers. Patients in the company’s study were grouped based on their levels of a brain protein, called tau, that predicts severity of cognitive problems. That led the FDA 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. The Indianapolis-based company conducted a 1,700-patient study showing patients who received monthly IV infusions of its drug declined about 35% more slowly than those who got a sham treatment, per the AP. The main safety issue with donanemab was brain swelling and bleeding, a problem common to amyloid-targeting drugs. Most cases identified in Lilly’s trial were mild.