Celebrex Database Clear Of Cardiovascular Signals, FDA’s Woodcock Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Data safety monitoring boards for ongoing prevention trials with Pfizer’s Celebrex say there is no indication the trials should be stopped. However, FDA is hesitant to make a final determination on Celebrex safety. The safety profile for Pfizer’s Bextra also is inconclusive, Woodcock says.
You may also be interested in...
Pfizer Celebrex Polyp Trial Shows Increase In Cardiovascular Events
The Adenoma Prevention with Celecoxib trial found an increased CV risk for patients taking 400 mg and 800 mg Celebrex compared to placebo; a second study showed no increased risk. The APC study results mean Pfizer can no longer promote the COX-2 as being clear of cardiovascular signals.
Pfizer Celebrex Polyp Trial Shows Increase In Cardiovascular Events
The Adenoma Prevention with Celecoxib trial found an increased CV risk for patients taking 400 mg and 800 mg Celebrex compared to placebo; a second study showed no increased risk. The APC study results mean Pfizer can no longer promote the COX-2 as being clear of cardiovascular signals.
GSK COX-2 Data Show No Short-Term Cardiovascular Risk, Company Says
Phase II agent has a safety profile similar to that of Celebrex but offers an “incremental” efficacy benefit over Pfizer’s drug, GSK says. NDA filing is tentatively scheduled for late 2006, but timing may depend on outcome of the Feb. 16-17 FDA advisory committee meeting on COX-2 safety issues.