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Refludan Coronary Syndrome Use Not Supported By Heparin-Placebo Data

Executive Summary

Aventis was unable to convince FDA and its Cardiovascular & Renal Drugs Advisory Committee that its thrombin inhibitor Refludan is superior to placebo in the treatment of acute coronary syndromes by inference from historical data comparing heparin and placebo.

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Aventis Refludan

Lepirudan (rDNA) for injection receives FDA "non-approvable" letter May 11 for treatment of anticoagulation in patients with acute coronary syndrome. The supplemental application was turned down by an FDA advisory committee May 2 (1"The Pink Sheet" May 8, p. 29). There are no ongoing or planned Refludan trials at this time, Aventis said

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