Shots:

• The EC’s approval is based on PLUTO study assessing Benlysta (10 mg/kg IV) + SoC vs PBO + SoC in 93 children aged 5 – 11yrs. and 12 – 17yrs. with systemic lupus erythematosus for 1yr. The EC’s approval follows recent approval in the US & Japan 
• The PLUTO study result: improvement in disease activity as assessed by SLE responder index response rate (52.8% vs 43.6%); patients with at least one AE and a serious AEs (79.2% and 17.0% vs 82.5% and 35.0%); PK & benefit-risk profile is consistent with adult SLE
• Benlysta is mAb targeting BLyS and has received approval for adults with SLE in the EU as an IV formulation in Jul’2011 and SC formulation in Nov’2017

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