Donanemab: Conflicts of interest found in FDA committee that approved new Alzheimer’s drug

Donanemab (marketed in the US as Kisunla ) was developed by Eli Lilly and approved by the US Food and Drug Administration ( FDA ) on 2 July .

FDA cited a “high rate’ of missing data and concluded that the “safety database was insufficient to adequately characterize the long-term safety” of the drug.

FDA also noted interim data showing an “imbalance” in overall deaths.

FDA is requiring Lilly to conduct a post-market “registry based, prospective, observational study” to track events, including deaths, brain haemorrhage, and oedema .

It is giving the company 13 years (until February 2037 ) to issue its final safety report.

Experts say drugs such as donanemab might be worsening neurodegeneration.

Federal law on conflicts of interest prohibits advisory members from having ties to companies that would have a “direct and predictable effect on the financial interests of the [adviser] or his employer.

FDA asks prospective members to declare past financial interests and “anything that would give an appearance’ of a conflict,” without specifying a timeframe.

The agency granted a waiver to two of the advisory members who were seated.