GSK’s Benlysta Bags Approval for Lupus Nephritis Treatment in China

China’s National Medical Products Administration (NMPA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard of care (SoC). 

The approval extends the current usage of belimumab as an add-on therapy in adults and children aged five years and older with active systemic lupus erythematosus (SLE) making Benlysta- China’s first and only biologic medicine approved for SLE and LN.

Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN) – what’s the connection?

Systemic Lupus Erythematosus (SLE) is the most common form of Lupus, a chronic autoimmune disease which is difficult to diagnose and even more challenging to treat. The symptoms include painful or swollen joints, extreme fatigue, unexplained fever, and skin rashes.

In Lupus Nephritis (LN), SLE causes inflammation of the small blood vessels in the kidney (glomeruli) leading to end-stage kidney disease, requiring dialysis or a kidney transplant. 

Despite improvements in diagnosis and treatment over the last few decades, LN remains one of the major causes of liver damage. Approximately 20% of patients with LN progress to end-stage kidney disease within ten years of diagnosis.

Related Article: FDA Approves Second Lupus Nephritis Drug in Two Months

Benlysta and Its Mode of Action 

Benlysta (belimumab) is a human monoclonal antibody which acts as a B-lymphocyte stimulator (BLyS) specific inhibitor by binding to soluble BLyS. Post binding, Benlysta inhibits the survival of B cells, including autoreactive B cells and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. 

For long Benlysta has been the only FDA approved medication and the first new lupus treatment in 50 years, although in the recent few years there are many players in the field including Astra Zeneca, Biogen, Calgene/BMS and even Abbvie who are now developing drugs for SLE.

Benlysta (belimumab) is also approved in China for five-year-old and older patients with active, autoantibody-positive SLE with high disease activity. It is also the first biologic in China’s 2021 National Reimbursement Drug List for paediatric SLE.

The present approval of Benlysta is based on results from a randomised, double-blind, placebo-controlled Phase III clinical trial that analysed the safety and efficacy of intravenous (IV) doses of 10mg/kg belimumab along with SoC in adults with active LN. 

The BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) phase III trial is the largest and longest trial conducted in active LN, involving 448 adult patients.

According to the findings, the treatment with belimumab plus SoC over two years boosted renal response rates and aided in lowering the risk of kidney disease deterioration in active LN patients versus SoC alone.

Professor Xueqing Yu, President of Guangdong Provincial People’s Hospital and principal BLISS-LN investigator, said: “With more than half of systemic lupus erythematosus patients experiencing some degree of renal involvement, the approval of belimumab is a much-needed new treatment option. Not only can belimumab help preserve the kidneys, but it can also facilitate a reduction in doses of steroids and immunosuppressants, which can have toxic side effects and lead to organ damage.”

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Author

Arvind C. Shekhar