NEW YORK CITY (dpa-AFX) - Bristol-Myers Squibb Co. (BMY) said that the U.S. FDA has approved a subcutaneous (SC) formulation of Orencia for the treatment of adults with moderate to severe rheumatoid arthritis. Orencia SC will be commercially available in the U.S. in September 2011.
Orencia is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
Orencia may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.
The new self-injectable formulation is a fixed 125 mg dose administered weekly through an injection under the skin following a single IV loading dose of approximately 10 mg/kg.
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