FDA approves subcutaneous formulation of Orencia

PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for injection under the skin to treat rheumatoid arthritis, Bristol said Friday.

The New York-based drug maker said the approval of Orencia (abatacept) for subcutaneous injection in patients with moderate to severe RA made it the first biotech drug for RA available in self-injectable and intravenous infusion formulations.

“Physicians now have a new option of a non anti-TNF, with a different mechanism of action, when administering a biologic in a subcutaneous formulation,” Stanford University Medical Center professor Mark Genovese said, referring to anti-tumor necrosis factor medications, biotech drugs that combat RA and other autoimmune disorders, by counteracting a protein that the body uses to combat tumors but also is involved in autoimmune diseases.

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