The priority review status means the company could have a decision in only six months time, rather than the 10 months wait usually applied to such decisions. This status is usually granted in cases where there are few existing treatments available for the condition in question. Ulcerative colitis (UC) is a chronic disease with no cure and no treatment for moderate to severe symptoms.
Remicade proved affective in improving symptoms during clinical trials of UC and is currently indicated for the treatment of rheumatoid arthritis, the spinal disease ankylosing spondylitis, and another difficult-to-treat inflammatory bowel disorder, Crohn’s disease (CD).
Clinical data was presented to the FDA in March 2005 for the consideration of Centocor’s application to market the drug for UC.
Dr Jerome Boscia, senior vice president of clinical research and development at Centocor, said: “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.”