GSK’s Benlysta (belimumab) Receives the US FDA’s Approval as the First Therapy for Active Lupus Nephritis (LN)

December 18, 2020 Auto Bot Benlysta, GSK, regulatory, US FDA’s Approval 0

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

Click here ­to­ read full press release/ article | Ref: GSK | Image: Euronews

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