Integrilin Fails To Get US Approval Recommendation

The US Food and Drug Administration's Cardiovascular and Renal DrugsAdvisory Committee decided at its meeting on February 28 that Cor Therapeutics' injectable platelet inhibitor Integrilin (intrifiban) needs more study.

The panel agreed that data from the single trial presented (IMPACT II) was positive and did show that the drug helped prevent complications in patients undergoing balloon angioplasty, but they felt that the data was not significant enough to overcome the usual requirement for two trials.

According to reports from the meeting, panel members did seem to be considering recommending approval, until the FDA's Robert Lipicky said that they could still agree the trial was positive even if they did not back the drug. Panel member Marvin Konstam of the New England Medical Center had commented that if the study was overwhelmingly clear, it would sway him to "back off the usual demand of a replicated trial."