Centocor, Inc., announced that the US Food and Drug Administration (FDA) have approved Remicade (infliximab) for the treatment of ankylosing spondylitis (AS). Remicade is now indicated for reducing signs and symptoms in active AS, a painful, progressive inflammatory condition of the spine that can result in fusion of the spinal vertebrae and structural damage to hips and other joints, which can lead to limited function and disability.

This approval is the second for Remicade in the US in the past three months. Remicade, in combination with methotrexate, was recently approved for use as first-line therapy for patients with moderately-to-severely active rheumatoid arthritis. These approvals continue to demonstrate the clinical benefit of Remicade across rheumatic diseases, a company release said.

"The approval of Remicade is a significant treatment development for patients suffering with AS," said Jerome A Boscia, M.D., senior vice president, Clinical Research and Development, Centocor, Inc. "Not only did patients in the trial experience rapid and sustained improvement in symptoms, including pain, stiffness and fatigue, they also experienced improvement in function and spinal mobility."

Remicade was first approved for the treatment of AS in the European Union (EU), making it the first biologic to receive approval from a major regulatory authority for this use. Remicade is currently approved for the treatment of AS in 58 countries, including the US.

Centocor, Inc., also announced that the existing Warning on Risk of Infections was updated to describe pneumonia and a Warning on Hepatotoxicity was added to the label for Remicade. This update describes rare post-marketing reports of severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis and provides recommendations for physician evaluation and treatment discontinuation, where appropriate, as well as information for patients (see prescribing information at www.remicade.com and Important Information below). These labelling changes are effective immediately and in agreement with the FDA, will be communicated to the medical community via a Dear Health Care Professional Letter this week.

Since August 24, 1998, when Remicade was approved in the US, approximately 576,000 patients have been treated with Remicade worldwide. Approximately three patients in controlled clinical trials and 35 patients in the voluntary post-marketing surveillance reported events considered to be severe hepatic reactions. A causal relationship between Remicade and these events has not been established.

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 RA and Crohn's disease in North America, the EU and Japan. In the EU, Remicade is indicated for the treatment of ankylosing spondylitis in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.

In September, the European Commission gave approval for expanded labeling for Remicade (infliximab), in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis (PsA) in patients who have responded inadequately to disease modifying anti-rheumatic drugs.

In the US, Remicade, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Remicade is the only biologic indicated for the treatment of patients with moderately-to-severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy. Remicade is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD.