By :- Team VOH
11 Jun 2024
A highly anticipated Alzheimer’s drug from Eli Lilly, donanemab, has gained the support of federal health advisers, paving the way for its expected approval for treating mild dementia caused by Alzheimer’s disease.
The Food and Drug Administration (FDA) advisers unanimously voted that the benefits of donanemab in slowing cognitive decline outweigh the associated risks, including side effects such as brain swelling and bleeding that require monitoring.
“I thought the evidence was very strong in the trial showing the effectiveness of the drug,” stated Dean Follmann, a statistician at the National Institutes of Health and panel member.
The FDA is set to make its final decision on the drug’s approval later this year. If approved, donanemab would become only the second Alzheimer’s drug in the U.S. to convincingly slow cognitive decline and memory problems due to Alzheimer’s, following the approval of Leqembi from Japanese drugmaker Eisai last year. Both drugs have shown to slow the progression of the disease by several months, though experts disagree on the perceptibility of this improvement by patients or their families.
Lilly's approach to studying donanemab involved grouping patients based on their levels of tau, a brain protein that indicates the severity of cognitive issues. This raised questions from FDA reviewers about whether patients might need to undergo brain scans for tau before receiving the drug. However, most panelists believed there was sufficient evidence of the drug’s benefits to prescribe it broadly without such screening.
“Imposing a requirement for 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.
In Lilly’s 1,700-patient study, those receiving monthly IV infusions of donanemab showed a 35% slower decline in cognitive functions compared to those receiving a placebo. The study’s results were similar to those of Leqembi, indicating a modest slowing of cognitive problems in early-stage Alzheimer’s patients.
The FDA had initially been expected to approve the drug in March but instead opted to have its panel of neurology experts publicly review the data, causing an unexpected delay.
Lilly’s study had several unique elements, including measuring tau levels and excluding patients with very low or no tau protein. Despite this, panelists felt confident that nearly all patients could benefit from the drug. Another distinctive feature was stopping the drug when patients reached very low levels of amyloid, a brain plaque linked to Alzheimer’s. This approach could reduce side effects and costs, though FDA staff noted that Lilly provided limited data on the optimal timing for stopping and restarting treatment.
The main safety concern with donanemab was brain swelling and bleeding, common issues with amyloid-targeting drugs. Most cases in the trial were mild, though three deaths linked to the drug involved brain complications. The FDA panel suggested that these risks could be managed with warning labels, doctor education, and medical scans to identify patients at higher risk.
Overall, the panelists viewed the potential to stop doses as a significant advantage, with Dr. Tanya Simuni of Northwestern University noting, “It’s a huge cost savings for society. We’re talking about expensive treatment and surveillance.” Patients will need to be monitored to determine the need for resuming treatment.
27 Jul 2024
27 Jul 2024
27 Jul 2024
26 Jul 2024
26 Jul 2024