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Home Industry News Janssen’s Simponi receives CHMP backing for ulcerative colitis

Janssen’s Simponi receives CHMP backing for ulcerative colitis

29th July 2013

Janssen has announced that its drug Simponi has received a new recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

The committee has endorsed the product for approval as a therapy for adult patients with moderate to severe ulcerative colitis who have had an inadequate response to conventional therapy, or who are intolerant to or have medical contraindications for such treatments.

Data from the Pursuit clinical trials have shown that the drug is able to deliver a long-lasting response among patients affected by the condition.

If approved, it would become the only biologic therapy available for this patient population that is administered subcutaneously every four weeks following an induction regimen.

Dr Jerome Boscia, vice-president and head of immunology development at Janssen's research and development division, said: "Adults living with this inflammatory bowel disease who remain uncontrolled on steroids or immunomodulators have limited treatment options today and Simponi would represent a new, subcutaneous therapeutic option."

This comes after Janssen's Simponi Aria was approved for the treatment of rheumatoid arthritis in the US earlier this month.ADNFCR-8000103-ID-801617725-ADNFCR

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