Abbott Laboratories’ Humira has scored a hat-trick in Europe, winning its third approval for the autoimmune disease ankylosing spondylitis.
The European Commission yesterday gave the go-ahead for the drug to treat severe, active forms of the condition, a chronic disease of the skeleton and joints that predominantly affects men in their thirties and forties. Symptoms include inflammatory back pain and stiffness, but the illness is also linked with other inflammatory diseases of the skin, eyes and intestines.
European regulators based their approval on results from the ATLAS (Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS) Trial, which showed that 58% patients receiving Humira experienced at least a 20% reduction in signs and symptoms of pain and inflammation at 12 weeks. In addition, the agent demonstrated its ability to reduce disease activity, inducing partial remission, improving physical function and improving physical quality of life, the company said.
The approval marks the third for Humira (adalimumab) in the autoimmune disease arena, having already gained clearance in Europe for the treatment of severe, active and progressive rheumatoid arthritis and psoriatic arthritis. This additional indication should give a nice boost to the product’s sales, which are already performing well, jumping 39% to $392 million in the first quarter of this year.
A similar application for AS is currently under review with the US Food and Drug Administration, and the agent’s potential is also being evaluated in other autoimmune diseases, such as Crohn's disease.