BMS Submits sBLA for Orencia

Bristol-Myers Squibb has completed FDA submission of its sBLA to license a third-party manufacturing facility to support increased production capacity for Orencia. The FDA approved Orencia in December 2005 for the treatment of rheumatoid arthritis (RA).

Orencia is indicated for reducing the signs and symptoms of RA, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate (MTX) or tumor necrosis factor (TNF) antagonists.