Janssen Biotech, Inc., formerly Centocor Ortho Biotech Inc., announced today that the Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administration (FDA) recommended the approval of 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. REMICADE® was designated orphan drug status by the FDA on November 12, 2003 for the treatment of pediatric UC, and the supplemental Biologics License Application (sBLA) received priority review following its submission to the FDA in December 2010.
REMICADE®, an anti-tumor necrosis factor (TNF)-alpha therapy, is currently approved for the treatment of adults with moderately to severely active UC, and adults and children with moderately to severely active Crohn's disease. In addition, REMICADE® is approved for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis and chronic, severe plaque psoriasis.
"We are pleased with the advisory committee's support for the approval of REMICADE® as a treatment for pediatric ulcerative colitis," said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Centocor Research & Development division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. "We hope the FDA will consider this recommendation and approve REMICADE® for this orphan disease."
The committee reviewed data from a Phase 3 randomized, multicenter, open-label trial evaluating the efficacy and safety of REMICADE® in the treatment of pediatric patients with moderately to severely active UC and voted the benefit:risk profile supports the approval of REMICADE® for pediatric UC indications including induction and maintenance of clinical remission and induction of mucosal healing. However, the committee did not recommend REMICADE for pediatric UC indications of maintenance of mucosal healing and eliminating corticosteroid use. Results from the trial were presented in May and showed that treatment with REMICADE® 5 mg/kg induced clinical response in 73 percent of patients at week 8 and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.
SOURCE Janssen Biotech, Inc.