The FDA admitted that the decision to remove [Dr. Sanjay] Kaul was made by agency staff that did not have the authority to unilaterally do so.Kaul was removed from a panel reviewing Lilly's application for Effient after he told Reuters that he believed the bleeding risks for Effient were less clear cut that Lilly claimed. Hinchey said:
The agency does not, however, refute Hinchey's argument that the decision was made after FDA officials consulted with Eli Lilly representatives.Hinchey's site does not provide the FDA letter itself, making it difficult to judge what it actually says.
This is the latest in a string of bad news for Lilly and Effient. The drug was approved with a black box warning last week; analysts curbed their estimates of its peak sales due to the price premium Lilly put on the drug.
The FDA "admission" is another cloud hanging over Effient. In addition to Lilly's maneuvering to ax Kaul from the panel, one of the docs involved in the drug's development wrote a letter urging that it not be approved until a "properly designed" phase 3 trial had been completed.
- See BNET's previous coverage of Eli Lilly and prasugrel:
- Analysts Rain on Lilly's Effient Parade; 70% of Sales Go Generic After 2011
- Prasugrel Doc Urges FDA to Nix Approval for Lilly Drug
- Lilly Advertises "Effient" Despite Lack of FDA Approval
- FDA's Prasugrel Machinations Seem Bound to Attract Doubt
- Lilly CEO Lechleiter's Prasugrel Bet Appears to Pay Off
- Odds Improve for Lilly's Prasugrel-ImClone Gamble
- In Light of Prasugrel Delay, Lilly-ImClone Deal Suddenly Makes Sense
- More Bad News for Lilly's Prasugrel