Centocor, Inc. has announced that the supplemental biologics license application (sBLA) for Remicade (infliximab) for the treatment of ulcerative colitis (UC) has been designated for priority review by the US FDA.
Remicade is the global market leader among anti-tumour necrosis factor alpha (TNF-alpha) therapies and the only agent approved for the treatment of both rheumatoid arthritis (RA) and CD in North America, the EU and Japan.
In Phase III clinical trials, Remicade was studied as a monotherapy to evaluate its impact on clinical response, clinical remission and mucosal healing in patients with moderately-to-severely active UC, a gastrointestinal disorder that affects more than one-half million Americans. Currently, there are no FDA-approved therapies to treat moderately-to-severely active UC, a condition that may cause patients to face surgical removal of the colon, otherwise known as a colectomy. Remicade is the only biologic indicated for the treatment of Crohn’s disease (CD), another difficult-to-treat inflammatory bowel disease (IBD), said a company release.
Centocor submitted the sBLA for Remicade for UC to the FDA in March 2005, based on data from the ACT 1 and ACT 2 clinical trials. Data from ACT 1 and ACT 2 were presented at the 36th Annual Digestive Disease Week.
Dr. Jerome A. Boscia, senior vice president, Clinical Research and Development, Centocor says, “Remicade, if approved for the treatment of UC, would represent a major breakthrough for patients with this serious disease. We look forward to working closely with the FDA as it reviews these data for approval.”
UC, a chronic inflammatory bowel disease affecting nearly 500,000 people in the US, is marked by the inflammation and ulceration of the colon mucosa, or innermost lining, which causes bloody stools, severe diarrhoea and frequent abdominal pain.