BMS Gets FDA Clearance of Rheumatoid Arthritis Drug
BMS says Orencia is the only biologic for treating RA that has been approved both in an intravenous infusion formulation and as a self-injectable subcutaneous formulation.
FDA approved a subcutaneous formulation of Bristol-Myers Squibb’s fusion protein drug Orencia (abatacept) for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA).
BMS says Orencia is the only biologic for treating RA that has been approved both in an intravenous infusion formulation and as a self-injectable subcutaneous formulation. The drug will be commercially available in the U.S. in September.
FDA clearance of subcutaneous Orencia was based on data from four clinical trials in nearly 2,000 patients, including a Phase III comparative registrational study, Acquire, in 1,457 patients. Most of the enrolled patients with moderate-to-severe active RA had demonstrated an inadequate respo
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