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Bristol-Myers Squibb Receives FDA Approval of Subcutaneous Formulation of ORENCIA for Rheumatoid Arthritis

Strategic Insights

— 1 min read

Bristol-Myers Squibb Company has announced that the US Food and Drug Administration (FDA) has approved a subcutaneous (SC) formulation of ORENCIA (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis (RA). This approval marks a significant milestone for the company, which now offers a biologic treatment in both subcutaneous and intravenous (IV) formulations for RA patients.

Key Takeaways:

  • The FDA approval of ORENCIA SC formulation is based on data from four clinical trials that studied nearly 2,000 patients, including the largest Phase 3 registrational trial of biologics in RA patients.
  • The subcutaneous formulation of ORENCIA can be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumour necrosis factor (TNF) antagonists.
  • 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 RA.
  • The Phase 3 comparative trial studied 1,457 patients, making it the single largest Phase 3 registrational trial of biologics in RA patients.
  • The ORENCIA SC development program is composed of four clinical trials that evaluated safety and immunogenicity in three clinical scenarios: patients receiving ORENCIA as monotherapy, patients withdrawn from and re-introduced to ORENCIA SC therapy, and patients switching from ORENCIA IV to ORENCIA SC therapy.

Statistics:

  • Over 2,000 patients were studied in the ORENCIA SC development program.
  • 1,457 patients were enrolled in the Phase 3 comparative trial.
  • The majority of patients (71%) had a moderate to severe disease activity.

Sources:

  • "Bristol-Myers Squibb Receives FDA Approval of Subcutaneous Formulation of ORENCIA (Abatacept) for the Treatment of Adults with Moderate to Severe Rheumatoid Arthritis." M2 EQUITYBITES, August 1, 2011. [www.m2.com](http://www.m2.com)

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