Pfizer says that 17 European countries have agreed to extend the label on its painkiller Celebrex to include symptomatic relief in the treatment of ankylosing spondylitis in adults, a form of arthritis that affects the spine.
Each of the countries will now individually update the licence for Celebrex (celecoxib) to include the new labelling, following applicable local procedures which, when done, will be the first oral selective COX-2 inhibitor available in Europe to treat the condition.
Ankylosing spondylitis causes inflammation that can lead to intense pain and stiffness in the shoulders, knees, hips, ribs and feet. In severe cases, it can cause the spine to fuse together and Rory O'Connor, Pfizer’s vice president of medical and regulatory affairs in Europe noted that the condition often affects young adults “in the prime of their most productive years.” He added that “Celebrex now offers an effective and well-tolerated treatment, adding to physician and patient choice in managing this devastating disease." Ankylosing spondylitis affects up to 0.9% of Europeans, the company noted.
Sweden acted as the European Union reference member state in the Mutual Recognition regulatory process that agreed to the extension. Celebrex was granted US Food and Drug Administration approval for the relief of ankylosing spondylitis in July 2005.
The extension is the latest bit of good news for COX-2s as they begin to shake off the association with serious cardiovascular side-effects that led to the withdrawal of Merck & Co's Vioxx (rofecoxib) and Pfizer's own Bextra (valdecoxib).