Centocor Ortho Biotech Inc and Schering-Plough Corporation announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion recommending the approval of Simponi (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderate-to-severe, active rheumatoid arthritis (RA), active and progressive psoriatic arthritis (PsA) and severe, active ankylosing spondylitis (AS).
Upon Commission approval in the European Union, Simponi given as a 50 mg subcutaneous injection once a month will be indicated for:
In combination with methotrexate, the treatment of moderate-to-severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drug (DMARD) therapy, including methotrexate, has been inadequate. Simponi has also been shown to improve physical function in this patient population.
Alone or in combination with methotrexate, the treatment of active and progressive PsA in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has also been shown to improve physical function in this patient population.
The treatment of severe, active AS in adult patients who have responded inadequately to conventional therapy.
"With this decision, Simponi moves one step closer to becoming the first once-monthly subcutaneous anti-TNF therapy for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in the European Union," said Jerome A Boscia, senior vice president, Clinical R&D, Centocor Research & Development, Inc. "We are optimistic that SIMPONI will be a welcome addition as a new anti-TNF treatment option for rheumatologists, and adults living with these inflammatory conditions who are seeking an effective and convenient therapy."
Upon receipt of the corresponding commission decision, Simponi will be the first and only once-monthly subcutaneous anti-tumour necrosis factor (TNF) alpha therapy approved in Europe for the simultaneous treatment of RA, PsA, and AS. Simponi will be available in two device forms, either through the SmartJect, a novel autoinjector designed to meet the needs of arthritis patients, or as a pre-filled syringe.
The CHMP recommendation serves as the basis for a European Commission approval decision. A commission approval of this application will result in marketing authorization with unified labelling that will be valid in all European Union Member States.
In April 2009, SIMPONI™ (golimumab) was approved by the U.S. Food and Drug Administration (FDA) and Health Canada for the treatment of moderately to severely active RA, active PsA and active AS.
"This positive opinion is an important step toward an approval as SIMPONI has the potential to benefit a broad range of patients in Europe by offering once-monthly subcutaneous treatment administered through an autoinjector device designed specifically with arthritis patients in mind," said Thomas P Koestler, executive vice president and president, Schering-Plough Research Institute. "Schering-Plough continues to pride itself on being a leading provider of rheumatic disease therapies within the European rheumatology community."
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. 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.
Centocor Ortho Biotech developed and discovered golimumab and has exclusive marketing rights to the product in the United States.
Simponi is a human monoclonal antibody that targets and neutralizes excess TNF alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.