The China’s Center for Drug Evaluation (CDE) website has indicated that Eli Lilly’s (NYSE: LLY) donanemab is set to receive priority review status for the treatment of early-stage Alzheimer’s disease (AD). This development is significant as it pertains to the drug’s potential use in patients with mild cognitive impairment or mild dementia, aligning with the patient population targeted in clinical trials.
Donanemab’s Mechanism and Recognition
Donanemab is a monoclonal antibody (mAb) that specifically binds to the β amyloid protein subtype N3pG, which is implicated in Alzheimer’s disease. By binding to this subtype, donanemab promotes the clearance of amyloid protein deposits in the brains of AD patients. This targeted approach has garnered donanemab breakthrough therapy designations (BTDs) in both the United States and China, highlighting its potential to significantly improve patient outcomes.
Regulatory Decision Timeline
A regulatory decision in the United States for donanemab was initially anticipated by the end of 2023. However, Eli Lilly disclosed in its Q3’23 financial report that the timeline for this decision has been extended to Q1 2024. This adjustment provides additional time for regulatory bodies to thoroughly review the drug’s efficacy and safety data before making a final determination on its approval.- Flcube.com
