FDA Approves Remicade For Crohn's Disease

The US Food and Drug Administration has granted marketing approval forCentocor's Remicade (infliximab) for the short-term treatment of patients with moderate-to-severe Crohn's disease who do not respond to conventional steroid and anti-inflammatory treatment, and also in patients with fistulizing Crohn's disease in order to reduce the number of draining entercutaneous fistulas.

It is the first drug designed specifically for Crohn's disease to gain approval in the USA, and the first new product to treat the disease in 30 years. Up to two million people worldwide are thought to suffer from the disease.

Long-term efficacy and steroid-sparing effects have yet to be established, but will be the subject of Centocor's post-marketing trials. Researchers will be especially looking to alleviate fears that long-term use of Remicade may cause malignancies or autoimmune disorders due to its mode of action; autoimmune antibodies have already been seen in some patients, but did not lead to clinical symptoms.