Abbott's Humira gets EU OK for AS

US health care major Abbott Laboratories says that the European Commission has approved its anti-tumor necrosis factor antibody-based therapeutic Humira (adalimumab), for use in the treatment of ankylosing spondylitis. AS is a disease of the axial skeleton that primarily causes inflammation and pain at the joints, although it can also damage the skin, eyes and intestines in a similar way to other autoimmune conditions.

The approval is based on data from the ATLAS trial, which showed that Humira was successful in reducing pain and inflammation in patients with active AS. Further analysis revealed that the drug brought about a reduction in disease activity, and partial remission, in many of the patients enrolled in the program. Additionally, the company reported that the level of adverse events observed in patients given the drug occurred at a similar rate in those who received placebo.

Abbott added that the drug, which is also indicated, in combination with methotrexate for the treatment of rheumatoid arthritis, and as a monotherapy for psoratic arthritis, has been granted marketing approval in 65 countries around the world. The firm went on to say that the product is also currently under examination for use in other inflammatory conditions.