Supplemental BLA submitted for Remicade for pediatric ulcerative colitis

Centocor Ortho Biotech announced that it submitted a supplemental Biologics License Application (sBLA) to the FDA for Remicade (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.  This sBLA is based on positive results from a randomized, open-label Phase 3 study that assessed the efficacy of induction and maintenance Remicade treatment in pediatric patients ages 6—17 years old who were diagnosed with moderately to severely active UC and had an inadequate response to treatment with conventional treatments, such as 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids, and/or 5-aminosalicylate (5-ASA).

Remicade is already approved for the treatment of moderately-to-severely active Crohn's disease in adult and pediatric patients with inadequate response to conventional therapy, fistulizing Crohn's disease in adults and moderately-to-severely active UC in adults with inadequate response to conventional therapy. Remicade is also indicated for severe chronic plaque psoriasis in adults who are candidates for systemic therapy and when other systemic therapies are medically less appropriate; to reduce signs/symptoms, inhibit progression of structural damage, and improve physical function in psoriatic arthritis and with methotrexate in moderately to severely active rheumatoid arthritis; and to reduce signs/symptoms of active ankylosing spondylitis.

For more information call (800) 457-6399 or visit www.centocororthobiotech.com.