(belimumab)

Voclosporin (Lupkynis) for Lupus Nephritis

Date:  August 23, 2021 Issue #:  1631 Summary:  Voclosporin (Lupkynis – Aurinia), an oral calcineurin inhibitor, has been approved by the FDA for use in combination with the antimetabolite immunosuppressant mycophenolate mofetil (Cellcept, and generics) and a corticosteroid for treatment of adults with active lupus nephritis. It is the first calcineurin inhibitor to be approved …

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GSK’s Benlysta (belimumab) Receives EC’s Approval for the Treatment of Active Lupus Nephritis

Shots: The MAA is based on a P-III BLISS-LN study assessing the efficacy and safety of belimumab (10 mg/kg, IV) + standard therapy vs PBO + standard therapy in 448 patients with active lupus nephritis for 104 wks. The study met its 1EPs i.e patients who achieved PERR @2yrs. (43% vs 32%) and has achieved …

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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 …

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

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 …

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