US Drug Regulator Delays Approval Decision on Eli Lilly’s Alzheimer’s Drug
The US Food and Drug Administration (FDA) has announced a delay in its approval decision for Eli Lilly’s groundbreaking Alzheimer’s disease drug, donanemab. The drug, which was expected to receive the green light this month, will now undergo further review by an advisory committee of independent experts. The FDA has expressed the need to better understand the safety and efficacy of donanemab, including the safety results in patients treated with the drug and the implications of its unique trial design.
This delay means that the FDA will take several months to convene the panel of experts, pushing the decision beyond the first quarter. Eli Lilly, based in Indianapolis, confirmed this setback in a statement. Finding an effective treatment for Alzheimer’s has proven to be an immense challenge for pharmaceutical companies, and previous regulatory decisions in this field have caused controversy.
In January, Biogen relinquished ownership rights to its Alzheimer’s drug Aduhelm after facing criticism over the accelerated approval process. The decision led to resignations from three independent experts at the FDA and scrutiny from two congressional committees. Donanemab, on the other hand, has shown great promise. Analysts project that it will reach blockbuster status with $1 billion in sales by 2026.
In a study involving 1,736 patients with early-stage Alzheimer’s, donanemab demonstrated its ability to slow cognitive decline. Nearly half of the participants who took the drug experienced no clinical progression after a year, compared to only 29% of those who received the placebo. Anne White, president of Lilly Neuroscience, expressed surprise at the FDA’s decision to convene an advisory committee at this stage but remained confident in donanemab’s potential to provide significant benefits to individuals with early symptomatic Alzheimer’s disease.
Similar to other Alzheimer’s treatments, donanemab targets and removes amyloid, a plaque that forms on the brains of patients and is associated with cognitive decline. Leqembi, an Alzheimer’s drug developed by Biogen and Japan-based pharma group Eisai, received FDA approval in July of last year. However, its rollout has been slower than anticipated, with only 2,000 US patients accessing the treatment by January 26, according to Eisai. Donanemab requires monthly infusions that take several hours and multiple MRI scans per year to monitor for side effects, particularly amyloid-related imaging abnormalities (Aria), which can lead to brain swelling and, in severe cases, be life-threatening. In contrast, Leqembi requires fortnightly infusions.
Eli Lilly pointed out that the approval process for both Aduhelm and Leqembi, which are also amyloid plaque-targeting treatments, involved similar additional advisory committee meetings. It is worth noting that the patients involved in the donanemab study had more advanced Alzheimer’s compared to those in similar studies.
The delay in the FDA’s approval decision for donanemab is undoubtedly disappointing news for Eli Lilly and the millions of individuals affected by Alzheimer’s disease. However, it is crucial to ensure that any new drug undergoes thorough evaluation to guarantee its safety and efficacy. The hope remains that donanemab will eventually receive approval and provide a much-needed breakthrough in the treatment of Alzheimer’s, offering a brighter future for patients and their families.