Eli Lilly‘s Alzheimer’s drug has won the backing of federal health advisers. This can play a crucial role in the treatment’s expected approval for people with mild dementia caused by Alzheimer’s disease.
According to a report by the news agency Associated Press, USFDA 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, the drug, donanemab, would only be the second Alzheimer’s drug cleared in the U.S. 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.
According to the report, the patients in the company’s study were grouped based on their levels of a brain protein, called tau, that predicts the 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. However, most panelists thought there was enough evidence of the drug’s benefit to prescribe it broadly, without screening for the protein.
“Requiring tau imaging is not necessary and would raise serious practical and access concerns to the treatment,” said Dr. Thomas Montine of Stanford University, who chaired the panel and summarized its opinion.
According to the AP report, the FDA had been widely expected to approve the drug in March. However, the agency said it would ask its panel of neurology experts to publicly review the company’s data, an unexpected delay that surprised analysts and investors. Se
Several unusual approaches in how Lilly tested its drug led to the meeting. One change was measuring patients’ tau, and excluding patients with very low or no levels of the protein. However, panelists said there was enough data from other measures to feel confident that nearly all patients could benefit from the drug, regardless of their levels.
Reportedly, the FDA’s panel agreed that those risks could be addressed by warning labels and education for doctors as well as medical scans to identify patients at greater risk of stroke.
