- The MAA is based on a P-III BLISS-LN study assessing the efficacy and safety of belimumab (10 mg/kg, IV) + standard therapy vs PBO + standard therapy in 448 patients with active lupus nephritis for 104 wks.
- The study met its 1EPs i.e patients who achieved PERR @2yrs. (43% vs 32%) and has achieved all major 2EPs, 49% reduction in the risk of patients experiencing renal-related events, results were consistent with the known safety profile of Benlysta
- Benlysta (IV, SC) is the first and only biologic approved for both SLE and LN in the EU. The EU’s MAA follows the recent approval for the similar expanded LN indication in the US
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