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Celebrex Label Extended for New Use in Europe
New York (ots/PRNewswire) -
- Celebrex to be Available in Europe for the Treatment of Ankylosing Spondylitis, a Debilitating Form of Arthritis
Pfizer Inc announced today that 17 European countries agreed to extend the Celebrex (celecoxib capsules) label to include symptomatic relief in the treatment of ankylosing spondylitis (in adults), a form of arthritis that affects the spine. Once each country updates its labeling, Celebrex will be the first oral selective COX-2 inhibitor available in Europe to treat this chronic and debilitating condition.
"Ankylosing Spondylitis is a very painful condition, often affecting young adults in the prime of their most productive years, said Rory O'Connor VP Medical & Regulatory Affairs, Europe. "Celebrex now offers an effective and well-tolerated treatment, adding to physician and patient choice in managing this devastating disease."
Ankylosing spondylitis is a form of arthritis that primarily affects the spine, causing 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. With its early onset and progressively damaging effects on the joints, ankylosing spondylitis poses a significant burden on patients and their families, as well as payers and healthcare budgets. Ankylosing spondylitis affects up to 0.9% of Europeans with wide geographic variation and differences among ethnic groups.
Sweden acted as the European Union reference member state in the Mutual Recognition regulatory process that agreed to ankylosing spondylitis as a new indication for Celebrex. Each of the 17 countries will now individually update the license for Celebrex to include the new labeling, following applicable local procedures. In the United States, Celebrex was granted Food and Drug Administration (FDA) approval for the relief of signs and symptoms of ankylosing spondylitis in July 2005.
Web site: http://www.pfizer.com
ots Originaltext: Pfizer Inc.
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