Janssen receives EU approval for new ulcerative colitis treatment

Janssen has announced that its new drug Simponi has been approved as a therapy for adult patients with moderate to severely active ulcerative colitis.

The drug has been ratified for use by the European Commission among people who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies.

It follows a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use, which was based on the positive performance of Simponi in the phase III clinical trial programme Pursuit.

Dr Jerome Boscia, vice-president and head of immunology development at Janssen Research and Development, said: "The European Commission approval of Simponi for the treatment of moderately to severely active ulcerative colitis is an important milestone for patients and the gastroenterology community."

This comes in the same week that European regulators also approved Janssen's drug Stelara as a therapy for active psoriatic arthritis.