A recent panel of independent advisors to the Food and Drug Administration recommended the approval of Eli Lilly’s Alzheimer’s drug donanemab. This comes as positive news for the more than 6 million Americans living with Alzheimer’s, as it would provide another treatment option for those suffering from the disease. The recommendation, if followed by the FDA, will expand the limited treatment options currently available in the U.S.
While the advisory panel unanimously agreed on the effectiveness of donanemab in treating Alzheimer’s patients in the early stages of the disease, concerns were raised regarding the need for more data, particularly in Black and Hispanic patients. The lack of diversity in clinical trials is a common issue in the medical field, and it is crucial to ensure that new treatments are effective across different demographic groups.
Donanemab would be the second Alzheimer’s drug of its kind on the U.S. market, following Biogen and Eisai’s Leqembi. Both drugs target amyloid plaque in the brain to slow the progression of the disease in patients at the early stages. However, it is important to note that these drugs are not cures and may come with potential risks, such as brain swelling and bleeding, which can be severe and even fatal in some cases.
During the phase three trial of donanemab, three patients died from severe cases of amyloid-related imaging abnormalities, highlighting the safety risks associated with the drug. Additionally, the rollout of Leqembi has been hindered by challenges such as the need for specialized diagnosis and monitoring, as well as the inconvenience of weekly infusions. These factors may impact the adoption and commercial success of donanemab in comparison to Leqembi.
The FDA advisory panel recommended that tau tests should not be required to access donanemab, as it could limit the population who can benefit from the drug. It is essential to strike a balance between ensuring the safety and effectiveness of the treatment while also expanding access to a broader patient population. MRI monitoring and other strategies should be implemented to mitigate the risks of brain swelling and bleeding associated with the drug.
The FDA recommendation for Eli Lilly’s Alzheimer’s drug donanemab has the potential to address the unmet medical need in treating Alzheimer’s patients. However, there are valid concerns raised by advisors regarding the need for more data, safety risks, and hurdles in the adoption of the treatment. Moving forward, it is crucial for regulatory agencies, pharmaceutical companies, and healthcare providers to work together to ensure that new treatments are safe, effective, and accessible to all patients in need.