First approval in EU for ReoPro plus stents

The European Union has approved an extended indication for EliLilly/Centocor's gpIIb/IIIa inhibitor ReoPro (abciximab) for use with stents during percutaneous coronary intervention. This is the first approval of ReoPro for this indication, with other European markets expected to follow within the next couple of months.

Clearance by the European Medicines Evaluation Agency follows the submission of data from the 2,399-patient EPISTENT trial which demonstrated a marked improvement in outcome following angioplasty using ReoPro plus stent versus stenting alone (Marketletter September 7, 1998). This study was supported by data from the ADMIRAL trial which involved 299 myocardial infarction patients undergoing PCI utilizing stenting in conjunction with ReoPro. At 30 days post-treatment, less than 11% of patients who had received the combined ReoPro and stent therapy had died, suffered a second MI or required urgent intervention, versus 20% of the placebo plus stent group. Overall, the reduction in risk for the ReoPro group was 45%.

According to Eli Lilly, which markets the drug in Europe, more than 60% of PTCAs performed in that market involve the use of stents. A spokesperson for the company said that theoretically, a license for stents could double the ReoPro market, although clinicians who were already aware of the EPISTENT data may have been using the drug off-label in this indication.