Centocor Remicade
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
nfliximab receives supplemental approval Dec. 29 for use in combination with methotrexate to inhibit "the progression of structural damage in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate." The agent was previously approved for use with methotrexate to reduce signs and symptoms of RA. For the new indication, Centocor has a Phase IV commitment to conduct a 1,000-patient study on the effects of infliximab on infections. The study, which is expected to begin in September, will assess the standard 3 mg/kg dose and a new 10 mg/kg dose that labeling says may be considered for patients with incomplete responses. A final study report is expected in September 200