EU approves subcutaneous formulation of Orencia (BMS) for moderate to severe Rheumatoid Arthritis

The European Commission has granted marketing authorization for the subcutaneous formulation of Orencia (abatacept), from BMS, in combination with methotrexate (MTX), for the treatment of adults with moderate to severe active Rheumatoid Arthritis (RA). The drug was previously approved for intravenous delivery so this extends the choice of administration route for patients and doctors. Approval of the subcutaneous formulation of abatacept is based on the ACQUIRE study, a pivotal Phase III registrational trial, as well as long-term efficacy and safety data from supporting Phase II studies. In ACQUIRE, the single largest Phase III registrational trial of biologics in RA patients, the subcutaneous and intravenous formulations of abatacept were compared and shown to be similar in terms of efficacy and safety (non-inferiority comparison).