Eli Lilly’s Alzheimer’s Drug Donanemab Receives Positive Recommendation from FDA Panel
Eli Lilly & Co.’s experimental drug for Alzheimer’s, donanemab, has received a positive recommendation from a panel of independent advisors to the Food and Drug Administration (FDA). The recommendation paves the way for the treatment to receive full approval in the U.S. later this year. If cleared for use, donanemab would become the second Alzheimer’s drug of its kind to enter the U.S. market, following Biogen and Eisai’s Leqembi.
The recommendation is significant as it would expand treatment options for the more than 6 million Americans who have Alzheimer’s, which is currently the fifth-leading cause of death for adults over 65. The drug has shown effectiveness in treating Alzheimer’s patients at the early stages of the disease. However, some advisors have noted the need for more data on donanemab in specific patient groups, such as Black and Hispanic individuals.
The recommendation also follows challenges faced by Eli Lilly in bringing the treatment to market. The FDA had previously called a last-minute meeting to review the safety and efficacy of the drug, causing delays. Additionally, the FDA had rejected the drug in January of last year due to insufficient data. Despite these setbacks, donanemab and Leqembi represent milestones in Alzheimer’s treatment after decades of failed efforts.
Both drugs are monoclonal antibodies that target amyloid plaque in the brain, a hallmark of Alzheimer’s, to slow the progression of the disease in patients at early stages. It is important to note, however, that neither drug is a cure. Treatment with drugs targeting amyloid plaque can come with risks such as brain swelling and bleeding. In fact, three patients in a late-stage trial of Eli Lilly’s drug died from severe cases of these side effects.
While Leqembi has faced hurdles in its rollout, including difficulties in diagnosing and monitoring Alzheimer’s, Biogen and Eisai have indicated that adoption of the treatment is increasing. On the other hand, analysts expect limited commercial adoption of donanemab compared to Leqembi due to its safety liabilities and less convenient administration. Donanemab is administered once a month through the veins, while Leqembi is currently administered through twice-monthly infusions.
To evaluate the effectiveness of Eli Lilly’s Alzheimer’s drug, a phase three trial was conducted on over 1,700 patients. The trial found that donanemab slowed the progression of Alzheimer’s by 29% compared to a placebo after around 18 months. These results are comparable to those seen with Leqembi. Patients in the trial needed to test positive for amyloid plaque and tau protein, another marker of Alzheimer’s severity. The trial mainly focused on patients with low-to-medium levels of tau, who appeared to benefit more from the treatment.
There has been some debate regarding the eligibility criteria for donanemab. Eli Lilly argued that testing for tau should not be required, as it would restrict the population who can benefit from the drug. Most advisors agreed with this perspective, stating that requiring tau tests would be an unnecessary barrier to access.
Despite its effectiveness, donanemab carries risks of brain swelling and bleeding. Around 24% of trial participants experienced brain swelling, and 31% experienced brain bleeding. Most cases were mild to moderate, with only a small percentage experiencing severe symptoms. The FDA is expected to include a strong warning about these risks in the drug’s label if it receives approval.
In conclusion, Eli Lilly’s Alzheimer’s drug donanemab has received a positive recommendation from the FDA panel. This development brings hope for expanded treatment options for Alzheimer’s patients in the U.S. If approved, donanemab would join Leqembi as a significant advancement in Alzheimer’s treatment. However, the drug’s safety liabilities and less convenient administration may limit its commercial adoption compared to Leqembi. The debate over eligibility criteria highlights the need to ensure access to the drug for all eligible patients. Despite the risks of brain swelling and bleeding associated with donanemab, the potential benefits it offers in slowing the progression of Alzheimer’s make it a promising development in the fight against this devastating disease.
