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| |  FDA Clears ReoPro For Expanded Labeling MALVERN, PA -- November 6, 1997 -- The U.S. Food and Drug Administration (FDA) has cleared the way for expanded use of Centocor, Inc.’s anti-platelet drug ReoPro(R) (abciximab) for use as adjunctive therapy to prevent cardiac ischemic complications in a broad range of patients undergoing percutaneous coronary intervention (PCI). The drug is also now indicated for unstable angina patients not responding to conventional medical therapy when PCI is planned within 24 hours. Previously, ReoPro was indicated solely for use in angioplasty patients at high risk for complications and was administered as a bolus 10 to 60 minutes before the procedure followed by a 12-hour continuous infusion. The expanded labeling allows physicians to use ReoPro in a broader population of patients undergoing PCI (balloon angioplasty, atherectomy and stent placement). In addition, in patients with refractory unstable angina, ReoPro can now be administered 18 to 24 hours before PCI, concluding one hour after the procedure. “The new labeling expands the number and type of patients who can benefit from ReoPro,” said Harlan Weisman, M.D., vice president of clinical research and biomedical operations at Centocor. “This is an important step toward reducing the total number of heart attacks and deaths in PCI patients.” Approximately 450,000 angioplasties are performed every year in the U.S. ReoPro reduces the complications associated with this procedure by preventing the formation of blood clots that commonly occur during the procedure. The expanded labeling for ReoPro is based on the results of two major clinical studies, EPILOG and CAPTURE. EPILOG (Evaluation of PTCA to Improve Long-term Outcome by c7E3 GP IIb/IIIa Receptor Blockade), published in June 1997 in The New England Journal of Medicine, showed a broad range of angioplasty patients treated with ReoPro and low-dose, weight-adjusted heparin had more than a 50 percent relative reduction at 30 days in their risk of the composite endpoint of death or heart attack compared with placebo. In the ReoPro group, 3.8 percent of patients suffered one of these events, compared with 9.1 percent of patients in the placebo group. The clinical benefits of ReoPro were similar, irrespective of the type of coronary intervention used (balloon angioplasty, atherectomy, stent placement). Results from the EPILOG trial show that bleeding, the most common side effect associated with ReoPro therapy, can be reduced by the use of modified dosing regimens and specific patient management techniques. In EPILOG, the incidence of major bleeding in patients treated with ReoPro and low-dose, weight-adjusted heparin was not significantly different from that in patients receiving placebo. The CAPTURE (c7E3 Fab Anti-Platelet Therapy in Unstable Refractory Angina) study, published in May 1997 in The Lancet, showed in patients with unstable angina who did not respond to conventional medical therapy, an 18-24-hour infusion of ReoPro prior to PCI and concluding one hour after the procedure reduced the risk of the composite endpoint of death, heart attack or the need for another emergency procedure such as repeat angioplasty or bypass surgery by nearly 30 percent, compared with placebo, at 30 days. As with EPIC (Evaluation of 7E3 for the Prevention of Ischemic Complications) and EPILOG, the 30-day CAPTURE results show the greatest effects on the MI and urgent intervention components of the composite endpoint. These components were analyzed for the period prior to intervention and from the start of intervention through Day 30. The greatest absolute difference in MI occurred in the post-intervention period (ReoPro 3.6 percent, placebo 6.1 percent). A reduction in MI also occurred prior to the intervention (ReoPro 0.6 percent, placebo 2.0 percent). ReoPro reduced the incidence of urgent interventions in the post-intervention period but did not affect mortality in either period. The CAPTURE trial incorporated weight adjustment of the standard heparin dose only during the performance of the intervention but, unlike EPILOG, did not investigate the effect of a lower heparin dose and arterial sheaths were left in place for approximately 40 hours. Bleeding rates were substantially decreased compared with those in EPIC but remained higher than placebo rates. ReoPro was developed by Centocor, Inc., and is manufactured by Centocor B.V. in Leiden, The Netherlands. Eli Lilly and Company distributes the product worldwide, except in Japan. Fujisawa Pharmaceuticals, Inc. will distribute ReoPro upon approval in Japan.
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