FDA Delays Approval of Eli Lilly’s Alzheimer’s Drug Donanemab, Citing Safety and Efficacy Concerns
March 8, 2024
Eli Lilly’s Alzheimer’s drug donanemab faces delays in FDA approval due to concerns over safety and efficacy, impacting the company’s prospects of tapping into a potential $2.8 billion market by 2028. The FDA’s decision to hold an advisory committee meeting stems from questions about the phase 3 TRAILBLAZER-ALZ 2 trial, particularly the med’s safety profile, efficacy, and unique trial design, including a limited-duration dosing regimen. The delay is unexpected for Lilly, which had anticipated approval by the end of this quarter. The TRAILBLAZER-ALZ 2 trial had shown promising results, with donanemab slowing cognitive decline by 35% and reducing the risk of progressing to the next stage of Alzheimer’s disease by 39% compared to a placebo. Lilly remains committed to working with the FDA and presenting further data to support donanemab’s approval.
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[Source: Fierce Pharma, March 8th, 2024]
