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GSK: FDA Approves BENLYSTA For Adult Patients With Active Lupus Nephritis In U.S.

GlaxoSmithKline plc (GSK,GSK.L) said Thursday that the U.S. Food and Drug Administration or FDA has approved BENLYSTA (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy.

Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE), the most common form of lupus. It can lead to end-stage kidney disease, requiring dialysis or a kidney transplant.

GlaxoSmithKline noted that the FDA approval extends the current indication in the U.S. to include both SLE and LN for both the intravenous and subcutaneous formulations.

The FDA approval for adult patients with active LN follows a Breakthrough Therapy Designation and Priority Review. The approval is based on the positive results of the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study.

The BLISS-LN study, the largest and longest phase 3 study conducted in active LN, involved 448 adult patients.

The study met its primary endpoint showing that a statistically significant greater number of patients achieved Primary Efficacy Renal Response (PERR) at two years when treated with BENLYSTA plus standard therapy, compared to placebo plus standard therapy in adults with active LN.

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