Abbott’s Humira approved for ulcerative colitis in Europe

Abbott has received European regulatory approval for its drug Humira to be used as a therapy for ulcerative colitis.

The European Commission has ratified the product for the treatment of moderate to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy, based on positive data from phase III clinical trials.

It is the seventh indication in which Humira has been approved in Europe since its introduction in 2003, with the drug also becoming the first self-injectable biologic therapy to be made available for this patient group.

Around 1.2 million people in the EU are currently affected by ulcerative colitis, a chronic inflammatory bowel disease that can lead to life-threatening complications.

Dr John Leonard, senior vice-president for pharmaceuticals research and development at Abbott, said: "This marks an important milestone in Abbott's continued commitment to advance science and help improve the standards of care for patients."

This comes after the company commenced a pair of new phase III studies for Humira last month, which will assess the efficacy of the drug as a treatment for hidradenitis suppurativa.