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Schering-Plough’s Remicade gets additional Australian approvals

The therapeutic goods administration of the Australian department of health and ageing has revised the indication of Schering-Plough's Remicade to include the treatment of early rheumatoid arthritis, and approved a new indication for psoriatic arthritis.

Remicade, in combination with methotrexate, can now be prescribed as first-line therapy for early rheumatoid arthritis (RA). 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 psoriatic arthritis (PsA) in adults where previous response to disease-modifying anti-rheumatic drugs (DMARDs) has been inadequate.

“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,” said Dr Robert Spiegel, chief medical officer and senior vice president, Schering-Plough.

Remicade is also indicated for treatment of ankylosing spondylitis and Crohn’s disease. The drug is a monoclonal antibody that specifically targets TNF-alpha, which has been shown to play a role in these diseases.