U.K. Clears ReoPro For Expanded Use
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U.K. Clears ReoPro For Expanded Use

MALVERN, PA -- November 25, 1997 -- The United Kingdom Medicines Control Agency has cleared the way for the expanded use of Centocor, Inc.’s antiplatelet drug ReoPro(R) (abciximab).

The U.K. is the first European Union member state to approve ReoPro for use as adjunctive therapy to prevent ischemic cardiac complications in a broad range of patients undergoing percutaneous coronary intervention (PCI). The expanded label also allows physicians to use the drug to reduce the short-term (one-month) risk of heart attack in unstable angina patients not responding to full conventional therapy and who are scheduled for PCI (including balloon angioplasty, atherectomy and bail-out stenting).

Under the European Union mutual recognition agreement process, it is anticipated that regulatory authorities from the other 14 EU countries will follow the United Kingdom and grant marketing clearance for the expanded use of ReoPro in the near future.

Previously, ReoPro was indicated solely for use in angioplasty patients at high risk for complications.

This year, more than 250,000 angioplasties will be performed in the European Union. ReoPro reduces the complications associated with this procedure by preventing the formation of blood clots that commonly occur during the procedure.

Earlier this month, the United States Food and Drug Administration cleared the way for the expanded use of ReoPro in a broad range of patients undergoing PCI as well as in unstable angina patients not responding to conventional medical therapy when PCI is planned within 24 hours.

More information on: ReoPro, Centocor, Inc.

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