US Approval For Centocor's ReoPro

In keeping with its long-standing tradition, the US Food and Drug Administration approved several products among its backlog of New Drug Applications towards the end of 1994. Among them was Centocor's glycoprotein IIb/IIIa antagonist, ReoPro (abciximab; c7E3), for the prevention of ischemic complications (abrupt vascular closure) in patients undergoing percutaneous transluminal coronary angioplasty.

Centocor has also received approval in the European Union for Reo-Pro via the multistate procedure (with the exception of Belgium which requires further trials of the agent), but pricing approvals and reimbursement issues are still pending. The product will be shipped from Centocor's manufacturing facilities in Leiden, the Netherlands, for marketing by Centocor and US partner Eli Lilly sometime in February.

ReoPro consists of the Fab fragment of the chimeric human-murine monoclonal antibody 7E3 which binds to the glycoprotein IIb/IIIa receptor on platelets, preventing them from binding to fibrinogen, von Willebrand factor and other adhesion molecules and thereby inhibiting platelet aggregation.