The approval sees Humira become the first and only self-injectable biologic therapy for UC in adults who have failed to respond to conventional therapy.
Marco Greco, Chairman of the European Federation of Crohn’s & Ulcerative Colitis Associations, said the approval “represents an important new therapeutic option”.
Humira is already indicated for the treatment of several other inflammatory diseases. Dr John Leonard, Senior Vice President, Pharmaceuticals R&D, Abbott, says the latest indication highlights the treatment’s usefulness.
He commented: “The approval of Humira for the treatment of moderately to severely active ulcerative colitis further demonstrates Humira’s versatility in treating a wide range of immune-mediated inflammatory diseases”.
UC is a chronic inflammatory bowel disease that causes ulcers in the colon and may eventually lead to life-threatening complications. Around 1.2 million Europeans suffer with UC.
“Having one more option to treat this disease provides new hope that some patients will be able to achieve remission of their disease,” said Marco Greco.
The approval of Humira – which was first approved in the EU in 2003 for the treatment of rheumatoid arthritis – was based on two Phase III global trials including more than 800 patients.