The EC has approved broadening the use of Abbott’s TNF antagonist Humira® to include the treatment of moderately active Crohn’s disease in adult patients who have demonstrated an inadequate response to conventional therapy. The antibody has been approved in the EU since 2007 for treating severely active Crohn’s disease. Clearance for the expanded indication was based on data from four Phase II/III studies evaluating the use of Humira to induce and maintain clinical remission in adult patients with moderately-to-severely active Crohn’s disease.
Humira is already marketed in Europe, the U.S., and in other markets for the treatment of other inflammatory diseases including (in specific territories) moderately-to-severely active rheumatoid arthritis, active and progressive psoriatic arthritis, active polyarticular juvenile idiopathic arthritis, moderate to severe chronic plaque psoriasis, moderately-to-severely active ulcerative colitis and severe axial spondyloarthritis.
Abbott reported $7.9 billion worldwide sales of Humira in 2011, compared with $6.5 billion in 2010, and $5.5 billion in 2009.