Janssen applies for approval of Simponi for ulcerative colitis

Janssen has submitted applications to regulators in the US and Europe for approval of its drug Simponi in a new indication.

The US Food and Drug Administration and European Medicines Agency (EMA) are to review the compound as a therapy for the treatment of adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Phase III clinical trials have demonstrated the safety and efficacy of the drug for this application, with this data set to be used to support the submissions.

Simponi is notable for being the first subcutaneous anti-tumour necrosis factor-alpha therapy to receive approvals in the US, Canada and the EU in 2009 for three rheumatic indications simultaneously.

Dr Jerome Boscia, vice-president and head of immunology development at Janssen's research and development division, said: "We look forward to collaborating with the health authorities on these submissions seeking approval of Simponi as a subcutaneously administered anti-tumour necrosis factor-alpha treatment for moderately to severely active ulcerative colitis."

Last month, the company submitted its new type 2 diabetes therapy canagliflozin for approval by the EMA.