Centocor's BLA has been submitted to the FDA requesting approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis. Golimumab is the company's next-generation human anti-TNF-alpha monoclonal antibody. It's being studied as an every four-week subcutaneous injection and as an intravenous (IV) infusion therapy. In February 2008, the company submitted a MAA to the EMEA for golimumab as a monthly subcutaneous treatment for the same indications.
The submission is based on five Phase III trials: golimumab as the first-line option in the treatment of early onset RA before methotrexate; golimumab for patients with active RA despite methotrexate use; and golimumab administered subcutaneously in patients with active RA and previously treated with biologic anti-TNF-alpha agent.