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Bristol-Myers Squibb's ORENCIA Receives FDA Approval for Subcutaneous Formulation in Treating Moderate to Severe Rheumatoid Arthritis

Strategic Insights

— 1 min read

Bristol-Myers Squibb's ORENCIA (abatacept) has been approved by the U.S. Food and Drug Administration (FDA) for a subcutaneous (SC) formulation in treating adults with moderate to severe rheumatoid arthritis (RA). This new formulation joins ORENCIA's existing intravenous (IV) infusion as a treatment option for patients with RA. 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.

Key Takeaways:

  • The FDA has approved a subcutaneous (SC) formulation of ORENCIA (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis (RA).
  • ORENCIA is the first and only biologic therapy for moderate to severe rheumatoid arthritis available in both subcutaneous injection and intravenous infusion formulations.
  • The subcutaneous 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.
  • Patients transitioning from ORENCIA IV to SC administration should administer the first SC dose instead of the next scheduled IV dose.
  • ORENCIA SC demonstrated similar efficacy and safety to ORENCIA IV in a large non-inferiority trial, with comparable ACR 20, ACR 50, and ACR 70 response rates.
  • The most common adverse events reported in greater than 5% of patients in either the SC or IV ORENCIA groups were headache, nasopharyngitis, upper respiratory tract infection, diarrhea, and nausea.
  • Serious adverse events occurred in 4.2% of patients in the ORENCIA SC plus methotrexate (MTX) group and 4.9% of patients in the ORENCIA IV plus MTX group.
  • ORENCIA SC is intended for use under the guidance of a physician or healthcare practitioner and will be commercially available in the U.S. in September 2011.

Statistics:

  • 1,457 patients participated in the Phase 3 registrational trial, ACQUIRE.
  • 94% of patients remaining in the study at month 6 were administered subcutaneous injections plus MTX.
  • Serious infections occurred in 0.7% of patients in the ORENCIA SC plus MTX group versus 1.4% of patients in the ORENCIA IV plus MTX group.
  • Malignancies occurred in 0.4% of patients in the ORENCIA SC plus MTX group versus 0.7% of patients in the ORENCIA IV plus MTX group.
  • Local subcutaneous injection-site reactions occurred in 2.6% of patients receiving ORENCIA SC plus MTX and 2.5% of patients receiving SC placebo plus MTX.

Sources:

  • Bristol-Myers Squibb Company press release
  • China Weekly News via VerticalNews.com

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