Centocor and Schering-Plough’s Remicade approved in spine disorder

Remicade (infliximab) is now indicated for reducing signs and symptoms in active ankylosing spondylitis (AS). This approval is the second for Remicade in the US in the past three months as Remicade, in combination with methotrexate, was recently approved for use as first-line therapy for patients with moderately-to-severely active rheumatoid arthritis.

“The approval of Remicade is a significant treatment development for patients suffering with AS,” said Dr Jerome Boscia, senior vice president of clinical R&D at Centocor. “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 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 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. These labeling changes are effective immediately.