CENTOCOR'S REOPRO NEARS APPROVAL

Centocor's monoclonal antibody-based treatment for preventing thrombosis in patients undergoing angioplasty, ReoPro (abciximab; formerly c7E3) has been recommended for approval by a US Food and Drug Administration advisory panel. Full approval will hinge on an FDA inspection of Centocor's production facilities for ReoPro in Leiden, the Netherlands, scheduled for end-June.

The panel voted 10-1 that ReoPro is safe and effective for the treatment of patients undergoing percutaneous transluminal coronary angioplasty who are at high risk of ischemic complications, based on the results of the 2,099-patient EPIC study. This revealed that the 30-day incidence of serious complications (death, myocardial infarction, and need for coronary artery bypass grafting or second PTCA), was 12.8% in the placebo group and 11.5% in the first ReoPro treatment group (bolus administration) and 8.3% in the second treatment group (bolus plus infusion).

The committee agreed that full approval of the drug should come only after the FDA and Centocor reach agreement on post-marketing studies to optimize the dose of ReoPro, and also to evaluate reduced adjunctive heparin doses. The committee were happy with the bolus dose (0.25mg/kg), but questioned the fact that the infusion is not weight adjusted.