Pfizer's Celebrex gets black box warning and new indication of AS

Pharmaceutical behemoth Pfizer has received good and bad news from the US Food and Drug Administration; the agency issued new warning labeling for the firm's COX-2 inhibitor Celebrex (celecoxib) but also granted approval for the drug's use in the treatment of signs and symptoms of ankylosing spondylitis, a form of arthritis that affects the spine.

The black box warning for Celebrex follows the FDA's review of all COX-2s earlier this year (Marketletter February 28), after the withdrawal by Merck & Co of its Vioxx (rofecoxib) last year on findings of increased risk of cardiovascular and gastrointestinal problems, and this impacted sales of the drug. However, for the second quarter of 2005, Pfizer reported that sales of its product have started to improve again, picking up some prescriptions from its withdrawn COX-2 Bextra (valdecoxib), and registering revenues of over $800.0 million for the three-month period (Marketletter July 25).

Pfizer's share price moved up $0.11 to $26.61 on the news of the FDA decision in August 1 trading, the day of the announcement.