Eli Lilly’s Alzheimer’s Drug Gains Support from US Health Advisers

Washington, D.C., The Gulf Observer: A highly anticipated Alzheimer’s drug developed by Eli Lilly has received unanimous backing from US federal health advisers, signaling a strong likelihood of the treatment’s approval for dementia caused by the debilitating disease.

On Monday, advisers to the Food and Drug Administration (FDA) voted unanimously in favor of the drug donanemab, concluding that its benefits in slowing Alzheimer’s disease progression outweigh its risks, which include potential side effects like brain swelling and bleeding that will need careful monitoring.

“I thought the evidence was very strong in the trial showing the effectiveness of the drug,” stated Dean Follmann, a statistician with the National Institutes of Health and a panel member.

The FDA is set to make a final decision on the drug’s approval later this year. Should the agency concur with the panel’s recommendation, donanemab would become only the second Alzheimer’s drug in the United States proven to significantly slow cognitive decline and memory loss caused by Alzheimer’s. Last year, the FDA approved a similar infused drug, Leqembi.

While both medications have shown a modest slowdown in cognitive decline, experts are divided on whether the improvement will be perceptible to patients and their families.

Eli Lilly’s innovative approach to studying its once-a-month treatment raised some questions among FDA reviewers. Patients in the study were categorized based on their levels of tau, a brain protein that indicates the severity of cognitive issues. This approach led the FDA to consider whether brain scans for tau would be necessary before prescribing the drug. However, most panelists believed the drug’s benefits were sufficient to warrant broad prescription 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 and summarized its opinion. He noted that Lilly’s results mirrored those of Leqembi, with both drugs showing a modest slowing of cognitive decline in patients with early-stage Alzheimer’s.

Lilly’s 1,700-patient study indicated that those receiving monthly IV infusions of donanemab experienced about a 35% slower decline compared to those who received a placebo. Despite the promising results, the FDA’s decision to have its panel review the data publicly caused an unexpected delay in the drug’s anticipated approval.

The FDA’s request for an advisory panel review stemmed from several unique aspects of Lilly’s study, including the measurement of patients’ tau levels and the exclusion of those with very low or no tau. Panelists, however, felt confident that nearly all patients could benefit from the drug, regardless of their tau levels.

Another distinctive feature of Lilly’s study was the strategy of discontinuing the drug when patients reached very low levels of amyloid, a sticky brain plaque linked to Alzheimer’s. Lilly proposed that stopping treatment could reduce side effects and costs, though the FDA staff noted a lack of data on the optimal timing and need for resumption of treatment.

Despite these uncertainties, many panelists were optimistic about the potential benefits of stopping doses. Dr. Tanya Simuni of Northwestern University highlighted the potential cost savings, emphasizing the need for patient tracking to determine the effectiveness and necessity of resuming treatment.

The primary safety concern with donanemab was brain swelling and bleeding, a common issue with amyloid-targeting drugs. Most cases in Lilly’s trial were mild, though three deaths linked to the drug were reported, all involving brain swelling or bleeding, with one caused by a stroke—a severe complication more frequent among Alzheimer’s patients.

The panel agreed that these risks could be mitigated through warning labels, doctor education, and medical scans to identify at-risk patients.

Eli Lilly’s donanemab now stands on the brink of potential FDA approval, promising a new avenue of hope for Alzheimer’s patients and their families.