Abbott gets EU recommendation for new Humira indication

The positive opinion is based on results from a phase III clinical trial named ATLAS. In October 2005, Abbott submitted a supplemental biologics license application (sBLA) with the FDA seeking approval to market Humira (adalimumab) as a treatment for ankylosing spondylitis (AS).

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 and intestines. In its severe form, AS over time can result in complete spinal fusion, causing extreme physical limitation.

“The positive opinion is encouraging news for European ankylosing spondylitis patients because it signals that a new treatment option will soon be available to address the symptoms of the disease,” said Dr Desiree van der Heijde, co-lead investigator of ATLAS and professor of rheumatology at the Maastricht University, the Netherlands.

The European Commission is expected to issue a decision granting the marketing authorization for Humira as a treatment of AS in the European Union within approximately 60 days.