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EU Approves Humira for Ankylosing Spondylitis

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Abbott received approval from the European Commission to market Humira as a treatment for severe, active ankylosing spondylitis (AS) in Europe. AS is a chronic disease of the axial skeleton and large peripheral joints that causes inflammatory back pain and stiffness, but is also associated with other inflammatory diseases of the skin, eyes and intestines. In its severe form, AS over time can result in complete spinal fusion, causing extreme physical limitation.

Humira also is approved in the EU for the treatment of severe, active and progressive rheumatoid arthritis and psoriatic arthritis. This approval follows a positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). Abbott’s application for Humira for AS in the U.S. is currently under review.

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