March 8, 2024

expert reaction to news that the FDA is convening an expert advisory committee meeting on the donanemab TRAILBLAZER-ALZ 2 study

Scientists react to news that the FDA are delaying a decision on the Alzheimer’s drug Donanemab. 

Prof Robert Howard, Professor of Old Age Psychiatry, UCL Division of Psychiatry, UCL, said:

“The FDA has decided to delay their licensing decision until an Advisory Committee of experts can determine whether the risks are justified by the benefits of the drug. This delay in granting a US license is a major blow for Lilly and their amyloid antibody donanemab and is based on concerns about the brain swelling and bleeding seen with the drug. These side-effects are about twice as common with donanemab than with Eisai’s drug lecanemab which already has a licence in the US. The balance between the very modest benefits of the amyloid antibody treatments for Alzheimer’s disease and the risks that they carry is under ever closer scrutiny as the gap between the hype and reality around these drugs narrows.”

*Press release from Eli Lilly: https://investor.lilly.com/news-releases/news-release-details/us-food-and-drug-administration-convene-advisory-committee

Declared interests

Prof Robert Howard: “No conflicts of interest.”