The European Commission has granted approval of Remicade (infliximab) in the European Union (EU), 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 (DMARDs), Schering-Plough Corporation and Centocor Inc have announced here.
The EU approval for Remicade as a treatment for psoriatic arthritis is based on data from IMPACT (Infliximab Multinational Psoriatic Arthritis Controlled Trial), a randomized, double-blind, placebo-controlled study involving 104 patients with active PsA who had failed at least one DMARD and were enrolled at nine study centres in the United States, Canada and Europe. Results demonstrated the safety and efficacy of Remicade in treating this debilitating disorder.
"This approval is an important milestone in the management of psoriatic arthritis as these patients now have a new treatment option that addresses the unique aspects of this difficult-to-treat disease," Robert Spiegel, chief medical officer and senior vice president, Schering-Plough said adding, "Moreover, the new indication further demonstrates the broad utility of Remicade in improving the lives of patients suffering from a range of inflammatory disorders."
Psoriatic arthritis is a chronic, autoimmune inflammatory condition involving the joints and the skin. The approval follows a positive opinion granted in July by the Committee for Medicinal Products for Human Use (CHMP), for the European Medicines Agency (EMEA).
The Arthritis Research Campaign estimates 1 in 50 people have psoriasis. Of these, about 1 in 14 will develop PsA. While PsA can develop at any age, onset usually occurs in middle-age, typically in adults between the ages of 30 and 50.
Remicade is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha which has been shown to play a role in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriasis, and may also be important in a wide range of other immune-mediated inflammatory disorders.
Unlike self-administered therapies that require patients to inject themselves frequently, Remicade is the only anti-TNF biologic administered directly under supervision and monitoring of specialized physicians, Schering-Plough claims in a release.
In the EU, Remicade is also indicated for treatment of AS in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.
Centocor has exclusive marketing rights to Remicade in the United States. Schering-Plough Corporation has rights to market Remicade in all other countries throughout the world, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd. markets the product.