sBLA Submitted for Simponi for Ulcerative Colitis

Janssen Biotech announced the submission of a supplemental Biologics License Application (sBLA) to the FDA requesting approval of Simponi (golimumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.  

In May 2012, findings from a Phase 3 investigational study reported the efficacy and safety of Simponi subcutaneous induction therapy in the treatment of moderately to severely active UC among patients who failed or were intolerant to conventional treatments.  Data from the Simponi Phase 3 UC maintenance study will be submitted for presentation in the future.

The application is supported by efficacy and safety findings from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT), which included Phase 3 multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of subcutaneous induction and every-four-week maintenance regimens of SIMPONI in adults with moderately to severely active UC.  All trial patients had failed to respond to or tolerate treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids and/or 5-aminosalicylate (5-ASA), or were corticosteroid dependent.  Study participants were naive to treatment with TNF inhibitors and had a baseline Mayo score between 6 and 12 and endoscopic subscore of ≥2. 

The induction trial (PURSUIT-SC) had an adaptive design with a Phase 2 dose-finding portion followed by a Phase 3 dose-confirming component.  The primary endpoint was clinical response at Week 6.  Secondary endpoints at Week 6 included clinical remission, mucosal healing and a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) scores.  Overall, 1,065 patients were treated in the study; 774 of these patients were randomized into the Phase 3 component of the study.  Patients responding to induction treatment with SIMPONI were eligible to continue in the Phase 3 PURSUIT-Maintenance study. 

Simponi is a human monoclonal antibody that targets and neutralizes excess TNF-α, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. Simponi is approved for the treatment of moderately to severely active RA with methotrexate, active psoriatic arthritis alone or with methotrexate and active ankylosing spondylitis.

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