European Regulators Reaffirm Pfizer's COX-2 Portfolio

Main Category: GastroIntestinal / Gastroenterology
Article Date: 04 May 2004 - 0:00 PST

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Pfizer Inc said today that European regulators have completed their safety assessment of the COX-2 specific inhibitor class and have reaffirmed the use of Pfizer's COX-2 specific inhibitor medicines Celebrex, Bextra and Dynastat 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 events and patients 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 the gastrointestinal side effects often associated with older, non-steroidal anti-inflammatory drugs (NSAIDs)."

One of the many studies that demonstrate the superior gastrointestinal safety profile of Celebrex involved more than 1.4 million elderly patients in Ontario, Canada of which over 15,000 were treated with Celebrex. This study showed that patients who took older NSAIDs were four times more likely to be hospitalized due to a gastrointestinal hemorrhage than patients who received Celebrex.

European regulators affirmed that Celebrex can be appropriately used in patients with cardiovascular disease based on the large body of data submitted by Pfizer. One of these studies, which included more than 22,000 patients, confirmed that those who received Celebrex were not at an increased risk of serious coronary heart disease compared to patients who received placebo or other pain medicines (rofecoxib, naproxen and ibuprofen).

Pfizer's COX-2 specific inhibitor portfolio consists of Celebrex and Bextra, both oral medicines indicated for the treatment of rheumatoid and osteoarthritis, as well as Dynastat, an injectable COX-2 specific inhibitor used to manage post-surgical pain.

Celebrex is the most widely prescribed COX-2 specific inhibitor in the world with over 42 million patients treated since its introduction in 1999.

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