Centocor Ortho’s Simponi Gets European Commission Approval

The European Commission has approved Simponi (alone or in combination with methotrexate) as a once-monthly, subcutaneous therapy for the treatment of moderate-to-severe, active rheumatoid arthritis, active and progressive psoriatic arthritis and severe, active ankylosing spondylitis.

Simponi is available in two device forms, either through the SmartJect, a autoinjector designed to meet the needs of arthritis patients, or as a prefilled syringe.

Reportedly, Centocor Ortho Biotech has developed and discovered Simponi and has exclusive marketing rights to the product in the US. Following regulatory approvals, Schering-Plough will assume exclusive marketing rights outside the US except in Japan, Indonesia and Taiwan.

The company said that the efficacy and safety of Simponi have been studied in a comprehensive phase 3 development program that included more than 2,000 patients living with moderately to severely active RA, active PsA and active AS.

However, in phase 3 rheumatoid arthritis trials, Simponi was shown to be effective regardless of prior treatment experience, which included patients inadequately responding to methotrexate and patients previously treated with anti-TNF agents.

Thomas Koestler, executive vice president and president at Schering-Plough Research Institute, said: “With this approval, Schering-Plough can now bring Simponi, in our development pipeline, to market in Europe. Offering once-monthly subcutaneous dosing, Simponi will provide an important and convenient new treatment option to rheumatologists and their patients.”