Genentech/Biogen Idec's Rituxan denied approval for earlier RA use
This article was originally published in Scrip
Executive Summary
The US FDA has issued a complete response letter to Genentech and Biogen Idec, denying an sBLA requesting permission to market Rituxan (rituximab) for use with methotrexate for rheumatoid arthritis (RA) patients who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), such as methotrexate.