Janssen Biotech, Inc., formerly Centocor Ortho Biotech Inc., announced that the Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) recommended the approval of Remicade  (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in paediatric 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 paediatric UC, and the supplemental Biologics License Application (sBLA) received priority review following its submission to the FDA in December 2010.

Remicade, an anti-tumour 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 paediatric 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, multi-centre, open-label trial evaluating the efficacy and safety of Remicade in the treatment of paediatric patients with moderately to severely active UC and voted the benefit:risk profile supports the approval of Remicade for paediatric UC indications including induction and maintenance of clinical remission and induction of mucosal healing.  However, the committee did not recommend Remicade for paediatric 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 per cent of patients at week 8 and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.  

GIDAC is convened upon request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of gastrointestinal diseases.  The committee provides non-binding recommendations based on its evaluation; the FDA is not bound by the committee's recommendation, but does take its advice into consideration.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon.  It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease.  An estimated 150,000 children under age 17 are living with debilitating symptoms of IBD.(1)  

Remicade was the first anti-tumoUr necrosis factor (TNF)-alpha treatment approved in the United States in August 1998 and the first TNF inhibitor to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology.  Remicade has demonstrated broad clinical utility with indications in Crohn's disease, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, ulcerative colitis (UC), paediatric Crohn's disease and psoriasis.  The safety and efficacy of Remicade have been well established in clinical trials over the past 17 years and through commercial experience with more than 1.5 million patients treated worldwide.

In the US, Remicade is approved for the following indications:

Reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA, when administered in combination with methotrexate.

Reducing signs and symptoms in patients with active ankylosing spondylitis;Reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.  

Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease.  

Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy.

Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis.  

Treatment of adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Remicade is unique among available anti-TNF-alpha biologic therapies.  It is the only anti-TNF-alpha biologic administered directly by caregivers in the clinic or office setting.  Remicade is a two-hour infusion administered every 6 or 8 weeks (indication-dependent), following a standard induction regimen that requires treatment at weeks 0, 2 and 6.  As a result, Remicade patients may require as few as six treatments each year as maintenance therapy.

Janssen Biotech, Inc. discovered and developed Remicade and markets the product in the United States.  The Janssen Pharmaceutical Companies market Remicade in Canada, Central and South America, the Middle East, Africa and Asia Pacific.

In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to Remicade to Mitsubishi Tanabe Pharma Corporation.  In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to Remicade to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co, Inc.  

Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen Biotech, Inc. has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease.