Subcutaneous formulation of ORENCIA® approved by European Commission

Bristol-Myers Squibb announced today that the European Commission has granted marketing authorisation for the subcutaneous formulation of ORENCIA® (abatacept), in combination with methotrexate (MTX), for the treatment of adults with moderate to severe active rheumatoid arthritis (RA).

 

Most of the currently available biologics for the treatment of RA are anti-TNF (anti-tumour necrosis factor) agents. Abatacept works through a different mechanism of action (T-cell co-stimulation modulation) and is the only agent available in both self-injectable, subcutaneous (SC) and intravenous (IV) formulations. Given that some patients prefer one route of administration for specific reasons, the availability of both formulations addresses the needs and preferences of patients and physicians.(1)

 

“ORENCIA is a true alternative to anti-TNFs – a first-line biologic therapy for RA patients that now also offers the convenience of self-administration in a subcutaneous formulation,” said Prof. Dr. Rieke Alten, Chief Physician, Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology Schlosspark Clinic, Berlin. “ORENCIA provides a choice when deciding how to treat adults with moderate to severe active RA by offering a proven mechanism of action that is different from anti-TNFs.”

 

The European 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).

 

The intravenous formulation of abatacept was first approved in the European Union in May 2007 and is a well-established treatment option for adult RA patients who have an inadequate response to methotrexate alone or who have failed a first biologic DMARD.

1. Scarpato S, et al. “Patient preferences in the choice of anti-TNF therapies in rheumatoid arthritis. Results from a questionnaire survey (RIVIERA study)” Rheumatology (2010) 49 (2): 289-294. doi: 10.1093/rheumatology/kep354. First published online: November 17, 2009