Abbott’s Humira receives expanded Crohn’s disease approval

Abbott has received European approval for Humira in an expanded Crohn's disease indication, based on positive data from clinical trials.

The European Commission has approved the drug for the treatment of moderately active Crohn's in adult patients who have had an inadequate response to conventional therapy.

Results from four phase II/III clinical studies showed that Humira is able to induce and maintain clinical remission among these patients, as well as offering convenience benefits thanks to its self-administered method of application.

Dr John Leonard, senior vice-president for pharmaceuticals research and development at Abbott, said: "This approval demonstrates Abbott's continued commitment to making Humira available to more patients with inflammatory bowel diseases and other immune-mediated disorders."

Humira has been approved for the treatment of severely active Crohn's since 2007 and is also indicated for use against several other inflammatory diseases, including rheumatoid arthritis, plaque psoriasis and ulcerative colitis.

It also received European Commission ratification as a severe axial spondyloarthritis therapy in July 2012.