J&J’s Cypher gets heart attack label in EU
This article was originally published in The Gray Sheet
Executive Summary
Johnson & Johnson/Cordis gains CE mark Aug. 27 allowing the firm to promote its Cypher Select Plus sirolimus-eluting stent in Europe as a treatment for acute myocardial infarction. The clearance is based primarily on data from the 712-patient TYPHOON trial that showed Cypher to have a statistically significant advantage over bare-metal stents (7.3% v. 14.3%) for heart attack patients in a composite target vessel failure endpoint measure. Even after the TYPHOON data was published in the New England Journal of Medicine in 2006, however, cardiologists remained cautious about use of drug-eluting stents as a primary AMI treatment, noting the challenge of assessing during an emergent procedure whether the patient is likely to comply with a long-term anti-clotting medication regime that may be necessary to prevent a late stent thrombosis event (1"The Gray Sheet" Sept. 18, 2006, p. 8). Cordis has no plans to bring Cypher Select Plus to the U.S., where AMI remains an off-label indication