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Pfizer Celebrex Revised Labeling Adds Class Cardio Risk, Moves Safety Data

Executive Summary

Pfizer appears to have used the relabeling of its COX-2 inhibitor Celebrex to add class cardiovascular risk language as an opportunity to renegotiate the placement of safety data

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Celebrex CV risk outweighs cancer benefit

Final analysis of Celebrex colon cancer prevention studies indicates cardiovascular risk "outweighs what may be an optimistic projection of its potential benefit in decreasing colorectal cancer events," editorial by Bruce Psaty and John Potter states. Pfizer's Adenoma Prevention with Celecoxib (APC) and Prevention of Colorectal Sporadic Adenomatous Polyps (PreSAP) trials were published in the New England Journal of Medicine Aug. 31. Celebrex labeling was updated to reflect the CV results of the trials last year (1"The Pink Sheet" Aug. 8, 2005, p. 6). Editorial also charges studies were too small to evaluate celecoxib's role in preventing colorectal cancer. "It is reasonable to conclude that celecoxib has no role as a chemopreventive agent either in patients with nonfamilial colonic adenomas or in the general population," the editorial concludes...

Celebrex CV risk outweighs cancer benefit

Final analysis of Celebrex colon cancer prevention studies indicates cardiovascular risk "outweighs what may be an optimistic projection of its potential benefit in decreasing colorectal cancer events," editorial by Bruce Psaty and John Potter states. Pfizer's Adenoma Prevention with Celecoxib (APC) and Prevention of Colorectal Sporadic Adenomatous Polyps (PreSAP) trials were published in the New England Journal of Medicine Aug. 31. Celebrex labeling was updated to reflect the CV results of the trials last year (1"The Pink Sheet" Aug. 8, 2005, p. 6). Editorial also charges studies were too small to evaluate celecoxib's role in preventing colorectal cancer. "It is reasonable to conclude that celecoxib has no role as a chemopreventive agent either in patients with nonfamilial colonic adenomas or in the general population," the editorial concludes...

Merck Arcoxia MEDAL Results Will Likely Not Meet FDA Gold Standard

Despite the release of positive results from a long-term cardiovascular safety trial of its Vioxx follow-on Arcoxia, Merck will likely need to conduct additional studies before receiving FDA approval of the COX-2 inhibitor

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