EU Approves Humira® Drug Against Ankylosing Spondylitis

Filed in archive Drugs, Vaccines and Therapeutics on June 8, 2006

EU regulatory bodies granted approval to market Humira® (adalimumab) in Europe. Humira is an arthritis drug from Abbott, indicated for severe, active ankylosing spondylitis (AS).

Ankylosing spondylitis is a form of arthritis affecting primarily the spine that not only causes severe chronic pain, but in advanced cases, may be debilitating as it can cause the spine to fuse.

"This approval of HUMIRA in the European Union is important in the treatment of ankylosing spondylitis, a debilitating disease that strikes young, mostly male patients in their thirties and forties," said Désirée van der Heijde, M.D., co-lead investigator of the ATLAS Phase III clinical trial and Professor of Rheumatology at the Maastricht University, The Netherlands. "Treatments like HUMIRA are changing how we can treat AS. The data in the clinical trial showed that treatment with HUMIRA significantly reduced the pain and inflammation caused by AS, and in some patients, led to partial remission."

Humira will be available immediately to patients in Germany, Spain, Finland and Denmark, with other EU countries to follow.

Further details, including a summary of clinical trial results may be found in Abbott's press release.

[Photo: Spondylitis.org]