Janssen Biotech, formerly Centocor Ortho Biotech, reported the Gastrointestinal Drugs Advisory Committee (GIDAC) of the FDA recommended the approval of REMICADER (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.
REMICADER was designated Orphan Drug status by the FDA in 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.
REMICADER, 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. REMICADER is also approved for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis and chronic, severe plaque psoriasis.
The committee reviewed data from a phase III randomized, multi-center, open-label trial evaluating the efficacy and safety of REMICADER in the treatment of pediatric patients with moderately to severely active UC and voted the benefit risk profile supports the approval of REMICADER 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 showed that treatment with REMICADER 5mg induced clinical response in 73% of patients at week eight and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.