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
Click here to read full press release/ article | Ref: GSK | Image: Caixin Global
The post GSK’s Benlysta (belimumab) Receives CHMP’s Opinion Recommending its Approval for Active Lupus Nephritis first appeared on PharmaShots.
