Shots:

• EMA’s CHMP has adopted a positive opinion recommending the use of Benlysta (IV- SC) in combination with background immunosuppressive therapies for the treatment of adult patients with active LN
• The opinion is based on a P-III BLISS-LN study assessing Benlysta (IV-10 mg/kg) + standard therapy vs PBO in 448 adult patients with active LN for 104wks. The study met its 1EPs i.e. greater number of patients achieved primary efficacy renal response @2yrs. (43% vs 32%) and has achieved all its 2EPs
• If approved- Benlysta would be the first and only biologic approved for both SLE and LN in the EU. The CHMP opinion follows the recent US FDA’s label expansion to include LN

­ Ref: GSK | Image: GSK