Bristol-Myers' subcutaneous Orencia OKed in EU; Biologics for RA

US drug major Bristol-Myers Squibb (NYSE: BMY) announced on Friday that the European Commission has granted marketing authorization 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-tumor 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 Rieke Alten, professor and chief physician, Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology Schlosspark Clinic, Berlin, Germany, adding: “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.”