GSK COX-2 Data Show No Short-Term Cardiovascular Risk, Company Says
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GSK COX-2 agent shows no short-term cardiovascular risk, firm reports. Phase II agent 406381 has similar safety profile to Celebrex but offers an "incremental" efficacy benefit over Pfizer’s drug, GSK says. NDA is tentatively planned for late 2006, but timing may depend on FDA advisory committee meeting on COX-2 safety