FDA Scrutinizes Eli Lilly's Alzheimer's Drug Candidate, Donanemab
The FDA's Advisory Committee is set to examine Eli Lilly's Alzheimer's drug candidate, donanemab, during a meeting on June 10. This review will focus on the trial's primary endpoint change, treatment cessation, and mortality reporting. Notably, donanemab's approval has encountered delays, prompting the FDA to extend its decision deadline to Q1 2024 and request further review via an AdCom. The anticipated close examination of tau biomarker-related data during the meeting suggests the agency's keen interest in this aspect. Additionally, concerns linger about the drug's dosing regimen and the potential impact of ceasing treatment based on amyloid plaque reduction on clinical outcomes. Should the drug be approved, its labeling will feature warnings pertaining to risks such as ARIA and cerebral hemorrhage, and Eli Lilly will be required to implement post-marketing risk strategies.
Key Takeaways
- FDA Advisory Committee will discuss Eli Lilly's Alzheimer's drug, donanemab, on June 10, focusing on trial design, data, and tau biomarker-related efficacy.
- GlobalData analysis projects donanemab's potential sales to reach $5.37bn by 2029.
- FDA disagrees with Lilly's change of primary endpoint from CDR-SB to iADRS.
- Approved donanemab's label will include risks of ARIA and cerebral haemorrhage.
Analysis
The FDA's scrutiny of Eli Lilly's donanemab underscores regulatory concerns regarding trial endpoint changes and the potential impacts of treatment cessation. This review could potentially delay market entry and consequently affect Eli Lilly's revenue projections, which are estimated to reach $5.37bn by 2029. Furthermore, the FDA's attention to tau biomarkers and dosing regimen reflects a cautious approach to drug safety and efficacy. If approved, contingent on stringent post-marketing surveillance, donanemab could set a precedent for Alzheimer's drug development, influencing future regulatory standards and pharmaceutical investment strategies. Conversely, rejection or further delays might dissuade similar innovative approaches in Alzheimer's treatment research.
Did You Know?
- Donanemab: An investigational monoclonal antibody developed by Eli Lilly for the treatment of Alzheimer's disease. It targets a modified form of beta-amyloid, a protein that forms plaques in the brains of Alzheimer's patients, believed to contribute to the disease's progression.
- Tau Biomarker: A protein found in neurons that can form tangles inside the brain cells of Alzheimer's patients, serving as a biomarker to evaluate disease progression and treatment efficacy.
- ARIA (Amyloid-Related Imaging Abnormalities): An observed side effect in some Alzheimer's patients treated with amyloid-targeting drugs, manifested as brain edema or hemorrhage, detected through MRI scans, posing a significant safety concern requiring careful management.