The US Food and Drug Administration has approved Bristol-Myers Squibb‘s subcutaneous formulation of Orencia (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis.
Orencia SC inhibits the progression of structural damage and improves physical function in adult patients with moderately to severely active rheumatoid arthritis.
A Phase III study of the drug involving 1,457 patients with the condition showed that comparable ACR 20, 50 and 70 response rates were achieved in patients receiving Orencia SC injections plus methotrexate or Orencia IV infusions plus methotrexate at month six.
The data also demonstrated that Orencia SC reported similar efficacy and safety to Orencia IV in a large non-inferiority trial.
The company said Orencia SC will be commercially available in the US in September 2011.