COR Withdraws Integrilin Application

COR Therapeutics has withdrawn its application for European marketingapproval of its antithrombotic gpIIb/IIIa inhibitor Integrilin (intrifiban) for use as an adjunct therapy to prevent acute cardiac ischemic complications in patients undergoing percutaneous transluminal coronary angioplasty. The decision was based on discussions with the European Medicines Evaluation Agency and Schering-Plough, COR's worldwide partner for the product.

In the USA earlier this year, a Food and Drug Administration advisory panel said that further study of the drug was required, and recommended against approval (Marketletter March 31). COR feels that the results of an additional 10,900-patient Phase III trial, which is now underway in unstable angina and non-Q wave myocardial infarction, could form the basis for a marketing approval application in this indication. Data from the study, called PURSUIT, are expected to be made available later this year, says the company.