A recent recommendation by a panel of independent advisors to the Food and Drug Administration (FDA) has opened the door for Eli Lilly’s Alzheimer’s drug, donanemab, to potentially receive full approval in the U.S. later this year. This recommendation comes after years of failed attempts to develop effective treatments for the debilitating disease that affects millions of Americans. However, despite the positive outlook, there are still concerns that need to be addressed before the drug can be widely adopted.
The panel of advisors highlighted the significant unmet medical need when it comes to treating Alzheimer’s disease. With over 6 million Americans diagnosed with the condition, there is a desperate need for effective treatments that can slow the progression of the disease. Donanemab is seen as a potential solution for patients at the early stages of Alzheimer’s, but more data is needed to ensure its safety and efficacy in various patient populations, particularly in Black and Hispanic communities.
Eli Lilly has faced numerous challenges in bringing donanemab to market, with the FDA calling for additional reviews of the drug’s safety and efficacy in late-stage trials. This cautious approach by the FDA comes in the wake of the controversial approval of another Alzheimer’s drug, Aduhelm, from Biogen and Eisai. The failed attempts to gain approval for donanemab in the past have highlighted the need for a more thorough evaluation of the drug before it can be deemed safe for widespread use.
Donanemab and Leqembi are both monoclonal antibodies that target amyloid plaque in the brain, a hallmark of Alzheimer’s disease. While both drugs have shown promise in slowing the progression of the disease in patients at the early stages, they also come with significant risks, including brain swelling and bleeding. The safety profile of donanemab, in particular, has raised concerns among experts, with some predicting limited adoption compared to Leqembi due to its less convenient dosing regimen.
Eli Lilly’s phase three trial on over 1,700 patients demonstrated a 29% reduction in the progression of Alzheimer’s compared to a placebo after 18 months of treatment. The trial focused on patients with low-to-medium levels of tau protein in the brain, which is considered a marker of Alzheimer’s severity. However, the exclusion of patients with no or very low levels of tau has raised questions about the drug’s efficacy in a broader population.
During the trial, a significant number of participants experienced brain swelling and bleeding, with some cases being severe and even fatal. The potential risks associated with donanemab, especially for patients with specific genetic markers, have prompted FDA staff to consider including a strong warning on the drug’s label. The need for regular monitoring through MRIs and other strategies is crucial to mitigate the risks associated with the drug.
The recommendation for the approval of Eli Lilly’s Alzheimer’s drug, donanemab, represents a significant step forward in the treatment of the disease. However, the safety concerns and the need for further data on its efficacy in diverse patient populations highlight the importance of a cautious approach to its approval. With more research and monitoring, donanemab could potentially provide much-needed relief for the millions of Americans suffering from Alzheimer’s disease.