Centocor, Schering Plough seek arthritis treatment approval
20 March 2008 00:00 in Medical Company Product News
Biomanufacturer Centocor and its development partner Schering-Plough have submitted a Marketing Authorisation Application to the European Medicines Agency for golimumab, an antibody for treating some forms of arthritis, the companies have confirmed.
The application is for golimumab to be marketed as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
At present, the drug - a next-generation human anti-TNF-alpha monoclonal antibody - is being studied as a subcutaneous injection administered every four weeks.
Findings from this research, which is evaluating the safety and effectiveness golimumab for over 1,400 adults with moderate to severe rheumatoid arthritis, will be presented at the European League Against Rheumatism's annual congress, which takes place in June.
Rheumatoid arthritis currently affects approximately 4.3 million people in the United States and Europe. Its cause is unknown.
Subject to European Union approval, Schering-Plough will assume exclusive rights for marketing golimumab in Europe.
Last year, the company recorded sales $12.7 billion (£6.41 billion) and invested $2.9 billion in research and development.
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