GSK’s Benlysta (belimumab) Receives CHMP’s Opinion Recommending its Approval for Active Lupus Nephritis

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

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