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Thursday, December 09, 2004
European regulators reaffirm Pfizer’s COX-2 medicine portfolio
European regulators have completed their safety assessment of the COX-2 specific inhibitor class and have recently reaffirmed the use of Pfizer’s COX-2 specific inhibitor medicines in a broad range of patients.
The review, which began in July 2002, was conducted by the Committee for Proprietary Medicinal Products and has been ratified by the European Commission. As part of the ratification, Pfizer will revise the labels of its COX-2 specific inhibitors to clarify for physicians how best to use these medicines in patients with cardiovascular disease, as well as patients at high risk of gastrointestinal problems and those who take low-dose aspirin.
“We are pleased that the Commission has affirmed the use of these important medicines for patients across Europe,” said Dr. Jack Watters, vice president of Medical and Regulatory Affairs for Pfizer Europe/Canada.
“Pfizer’s COX-2 specific inhibitor medicines have been studied in tens of thousands of patients worldwide and have been shown to be not only effective in reducing pain and inflammation, but do so with less risk of gastrointestinal side effects often associated with older, non-steroidal anti-inflammatory drugs (NSAIDs),” Watters added.
One of the many studies that demonstrates the superior gastrointestinal safety profile of one of the COX-2 specific inhibitor medicines, Celecoxib, involved more than 1.4 million elderly patients in Ontario, Canada of which over 15,000 were treated with the medicine. This study showed that patients who took older NSAIDs were four times more likely to be hospitalized due to gastrointestinal hemorrhage than patients who received Celecoxib.
European regulators affirmed that Celecoxib could be appropriately used in patients with cardiovascular disease based on the large body of data submitted to support the same. One of these studies, which included more than 22,000 patients, confirmed that those who received Celecoxib were not at an increased risk of serious coronary heart disease compared to patients who received placebo or other pain medicines.
Pfizer’s COX-2 specific inhibitor portfolio consists of oral medicines indicated for the treatment of rheumatoid and osteoarthritis, as well as an injectable COX-2 specific inhibitor used to manage post-surgical pain.
(December 9, 2004 issue)
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