Recently, a panel of independent advisors to the Food and Drug Administration (FDA) recommended the approval of Eli Lilly’s Alzheimer’s drug donanemab. This move has the potential to provide a new treatment option for the more than 6 million Americans suffering from Alzheimer’s disease. If cleared for use, donanemab would become the second Alzheimer’s drug in the U.S. market, following another treatment called Leqembi from Biogen and Eisai. The FDA typically follows the recommendations of its advisory panels, although it is not obligated to do so.
During the meeting, several advisors expressed the need for more data on donanemab in specific patient groups, such as Black and Hispanic individuals. Despite the efficacy shown in early-stage Alzheimer’s patients, there is still a gap in knowledge regarding the drug’s effectiveness in diverse populations. The unanimous agreement that the benefits of donanemab outweigh its risks is reassuring, but the call for further research highlights the importance of comprehensive data collection.
The road to approval for donanemab has been fraught with obstacles for Eli Lilly. The FDA’s decision to convene a last-minute meeting to review the drug’s safety and efficacy in a late-stage trial added to the uncertainties surrounding the treatment. Furthermore, the rejection of the drug in January last year due to insufficient data raised questions about its overall effectiveness. These setbacks have created a sense of caution around the approval process for donanemab.
Both Leqembi and donanemab represent significant advancements in Alzheimer’s treatment after decades of failed attempts to develop effective medications. However, it is crucial to acknowledge the limitations of these drugs, particularly in terms of side effects. Drugs targeting amyloid plaque in the brain, such as donanemab, can lead to brain swelling and bleeding, posing risks to patients. The incidence of severe side effects, as seen in cases of amyloid-related imaging abnormalities (ARIA), underscores the importance of careful monitoring and evaluation.
The criteria for patient eligibility in clinical trials and subsequent treatment with donanemab remains a point of discussion. The emphasis on testing for amyloid plaque, as opposed to tau protein levels, raises questions about the specificity of the drug’s effects. While targeting amyloid plaque may slow the progression of Alzheimer’s, the exclusion of patients with low tau levels from the primary analysis could limit the drug’s potential impact. The balance between inclusion criteria and treatment outcomes requires careful consideration.
As donanemab nears potential approval, considerations about patient care and adherence come to the forefront. The implications of allowing patients to discontinue treatment based on amyloid clearance raise questions about long-term management strategies. Moreover, the incidence of side effects, such as brain swelling and bleeding, necessitates robust monitoring protocols to ensure patient safety. The anticipated inclusion of a boxed warning in the drug’s label reflects the need for clear communication about risks associated with treatment.
The FDA’s recommendation for the approval of Eli Lilly’s Alzheimer’s drug donanemab marks a significant milestone in the treatment of this devastating disease. While the potential benefits for patients are promising, it is crucial to approach the approval process with a critical lens. Addressing concerns about data collection, patient eligibility, and safety considerations will be essential in ensuring that donanemab delivers on its therapeutic promise while prioritizing patient well-being.