FDA Approves New Administration Option for Orencia in pJIA

Approval is based on a study that consisted of a 4 month short-term period followed by a 20-month extension
Approval is based on a study that consisted of a 4 month short-term period followed by a 20-month extension

Bristol-Myers Squibb announced the launch of Orencia (abatacept) subcutaneous (SC) injection, a new administration option for patients aged ≥2 years with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). 

Orencia, a selective T-cell costimulation modulator, was initially approved as an intravenous (IV) formulation in 2008 as the first biologic for use in patients aged ≥6 years with moderately to severely active polyarticular JIA. The prefilled syringe is a new option allowing administration at home. Orencia SC is given once-weekly using weight-tiered dosing. 

The approval of the prefilled syringe was based on dosing, efficacy, and safety data of SC abatacept in JIA among patients aged 2–17 years with inadequate response to at least one nonbiologic or biologic DMARD (Study JIA-2). The Phase 3 study consisted of a 4-month short-term period followed by a 20-month open-label extension period. 

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At baseline, 80% of patients were taking methotrexate and remained on a stable dose. At 4 months, the JIA ACR 30, 50, and 70 response rates were 81%, 71%,  and 53%, respectively. These data were consistent with those seen from the IV study (Study JIA-1). 

Orencia is now available as a 250mg lyophilized powder for IV infusion; 50mg/0.4mL, 87.5mg/0.7mL, 125mg/mL strength solution in prefilled syringe for SC injection; and as 125mg/mL strength solution in prefilled ClickJect autoinjector for SC injection. 

For more information call (800) 673-6242 or visit Orencia.com.