Shots:

• The approval follows BTD and PR & is based on P-lll BLISS-LN study involves assessing Benlysta (IV- 10 mg/kg) + SOC vs PBO + SOC in 448 adult patients with active LN
• The study met its 1EPs demonstrating a greater number of patients who achieved PERR @2yrs. (43% vs 32%.- all 2EPs were achieved while safety results are consistent with the known safety profile of Benlysta
• Benlysta is a mAb that binds to soluble BLyS and does not bind B cells directly. The approval extends the current indication in the US to include both SLE and LN for both the IV and SC formulations

 ­ Ref: GSK | Image: GSK