June 30, 2008
Centocor Files Application for Approval of Arthritis Drug
Centocor has submitted a biologics license application to the FDA requesting the approval of golimumab as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Golimumab, Centocor's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four week subcutaneous injection and is also being studied as an intravenous (IV) infusion therapy.
Jerome Boscia, senior vice president, clinical R&D, Centocor, said: "This submission marks a major milestone in the clinical development program of golimumab, and we look forward to working with the FDA to bring golimumab to market."