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
You may also be interested in...
Vioxx Cardiovascular Safety Questioned In Original NDA, Review Docs Show
The need for additional studies to assess the potential for increased cardiovascular events with Merck’s Vioxx was cited in FDA’s original review, according to NDA review documents for the COX-2 inhibitor.