FDA accepts for review Bristol-Myers Squibb's ORENCIA sBLA for severe RA

Bristol-Myers SquibbDec 7 2010

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the subcutaneous formulation of ORENCIA® (abatacept), a treatment for adult patients with moderate to severe rheumatoid arthritis (RA) administered through an injection into the skin. Bristol-Myers Squibb submitted the sBLA to the FDA for the subcutaneous formulation of ORENCIA and received confirmation of its receipt on October 4, 2010.

The sBLA for ORENCIA is based on clinical data from four multinational Phase III trials. A total of 1,847 adult patients with moderate to severe rheumatoid arthritis were treated with ORENCIA during the Phase III clinical trial program, which studied

• efficacy and safety of subcutaneous versus intravenous (I.V.) ORENCIA in patients with inadequate response to methotrexate;
• immunogenicity and safety with or without methotrexate in the absence of an I.V. loading dose;
• immunogenicity and maintenance of efficacy in patients who switched from long-term I.V. ORENCIA to subcutaneous ORENCIA; and
• immunogenicity, safety and efficacy during withdrawal and re-administration of subcutaneous ORENCIA with and without an I.V. loading dose.