Remicade (infliximab) gains Australian approval for treatment of early rheumatoid arthritis

Schering-Plough Corporation today announced that the Therapeutic Goods Administration of the Department of Health and Ageing in Australia has revised the indication of Remicade (infliximab) to include the treatment of early rheumatoid arthritis (RA) and approved a new indication for psoriatic arthritis (PsA).

Remicade, in combination with methotrexate, can now be prescribed as first-line therapy for early rheumatoid arthritis. Previously patients were required to be treated first with methotrexate alone, prior to the addition of Remicade therapy. Additionally, Remicade is now indicated for the treatment of signs and symptoms of active PsA in adults where previous response to disease-modifying anti-rheumatic drugs (DMARDs) has been inadequate.

"These approvals represent important developments in the management of early RA and Psoriatic Arthritis in Australia. Patients will now have new treatment options that inhibit the progression of joint structural damage in early RA and in Psoriatic Arthritis a therapy that improves signs and symptoms of joint disease as well as helps clear skin lesions," said Robert Spiegel, MD, chief medical officer and senior vice president, Schering-Plough. "Remicade continues to expand its proven efficacy and safety profile and demonstrate its clinical value among biological therapies in treating a host of immune-mediated inflammatory disorders."

In Australia, Remicade, in combination with methotrexate, is currently indicated for the reduction of signs and symptoms and prevention of structural damage (joint erosions and joint space narrowing) in patients with active rheumatoid arthritis despite treatment with methotrexate. Remicade is also indicated for the reduction of signs and symptoms and improvement in physical function in patients with active Ankylosing Spondylitis.

For patients with Crohn's disease, Remicade is indicated in the treatment of moderate to severe disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have inadequate response to conventional therapies. Remicade is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with Crohn's disease.