Centocor Ortho Biotech Inc and Schering-Plough Corporation announced that the European Commission has approved 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).
In the European Union, Simponi is approved as a 50 mg subcutaneous injection once a month and is indicated - in combination with methotrexate, for 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, for 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.
For the treatment of severe, active AS in adult patients who have responded inadequately to conventional therapy.
Centocor Ortho Biotech developed and discovered Simponi and has exclusive marketing rights to the product in the United States. Following regulatory approvals, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan, where Simponi will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where Simponi will be exclusively marketed by Janssen-Cilag; and China, where Simponi will be exclusively marketed by Xian-Janssen. Centocor Ortho Biotech, Janssen-Cilag and Xian-Janssen are wholly-owned subsidiaries of Johnson & Johnson.
"With this approval, Schering-Plough can now bring Simponi, one of the five stars in our development pipeline, to market in Europe," said Thomas P Koestler, executive vice president and president, Schering-Plough Research Institute. "Offering once-monthly subcutaneous dosing, Simponi will provide an important and convenient new treatment option to rheumatologists and their patients. Simponi expands upon our leading immunology franchise in meeting the needs of the rheumatology community."
Simponi is 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 is available in two device forms, either through the SmartJect, a novel autoinjector designed to meet the needs of arthritis patients, or as a prefilled syringe.
"Simponi has been shown to significantly reduce the signs and symptoms and improve physical function of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, three debilitating rheumatic diseases," said Iain B McInnes, professor of Experimental Medicine, University of Glasgow, study investigator. "With this approval, rheumatologists and patients now have an effective once-monthly subcutaneous anti-TNF therapy for the treatment of these rheumatic diseases."
The Commission Decision follows a positive opinion adopted on June 25, 2009, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) and results in marketing authorization with unified labelling that is valid in the current EU 27 member states as well as in Iceland and Norway. In April 2009, Simponi (golimumab) was approved by the US Food and Drug Administration (FDA) and Health Canada for the treatment of moderately to severely active RA, active PsA and active AS.
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.
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.