Drugs

Conflict of Interest Seen in Kisunla Approval

Writing in BMJ, two U.S.-based investigative journalists are raising issues of conflict of interest on the FDA advisory committee that recommended approval of Lilly’s Kisunla (donanemab) Alzheimer’s drug. FDA approved the drug 7/2.

A 1/2023 FDA letter to Lilly denying approval of Kisunla cited a “high rate” of missing data and said the safety database was insufficient to adequately characterize the drug’s long-term safety. While Lilly retained a third-party contractor to find the missing data, experts interviewed for the article said it was impossible to assess the reliability of the new data since the company declined to identify its contractor and discuss the methods used to obtain the data.

Because of safety concerns, the article says, FDA is requiring Lilly to conduct a postmarket study to track events including deaths, brain hemorrhage, and edema. The authors report the agency gave the company 13 years to submit its final report, a deadline that National Center for Health Research president Diana Zuckerman said “shows indifference to the needs of patients and their families despite clear concerns about the potential increase in irreparable harm and deaths that would be evident after just a few years.”

The reporters cite the furor that erupted over FDA’s approval of Biogen and Eisai’s Aduhelm (aducanumab) despite a unanimous (with one abstention) vote not to recommend the drug by an advisory committee. When Eisai and Biogen’s Leqembi (lecanemab) was approved in 2023, FDA had appointed new members to the advisory committee, all of whom, or their employers, had financial ties to Biogen and Eisai from 2017 through 2023. The committee unanimously recommended approval and FDA authorized the drug in 7/2023.

For Kisunla, the article says, FDA expanded the advisory committee to 11 members, including eight physicians. BMJ found “relevant” financial interests for nine of the committee members, with no data available for one member and no relevant interests for the 11th person.

When the authors asked FDA about the extensive financial conflicts among committee members, the agency response was, “FDA does not comment on matters related to individual members of an advisory committee.”

The article concludes by raising questions about Kisunla’s efficacy based on issues in the clinical trial, including a change in the Alzheimer’s disease rating scale used as the primary endpoint.

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