Shots:

• The approval was based on the P-III (BLISS-LN) trial to evaluate the efficacy & safety of belimumab (10mg/kg, IV) + SoC vs PBO + SoC in 448 adult patients with active LN
• The trial met its 1EPs i.e., patients treated with belimumab achieved PERR (43% vs 32%) @~2yrs. The 2EPs were also met including complete renal response @2yr. and time to renal-related event or death. The results were consistent with the known safety profile of belimumab + SoC in patients with SLE & helps to reduce the risk of worsening of kidney disease
• Benlysta is a BLyS specific inhibitor that binds to soluble BLyS & is approved in China for those aged ≥5yr. with active, autoantibody-positive SLE with high disease activity

Ref: GSK | Image: GSK