First and only biologic approved in China for both systemic lupus erythematosus and lupus nephritis
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that 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. The approval extends the current indication in China as add-on therapy in adults and children aged five years and older with active systemic lupus erythematosus (SLE). This approval makes belimumab China’s first and only biologic medicine approved for SLE and LN.
Hal Barron, Chief Scientific Officer, and President R&D, GSK said: “Nearly 500,000 people in China have systemic lupus erythematosus and more than half of these patients will develop one of the most common and serious complications, lupus nephritis.[i],[ii] Recognising that lupus nephritis can lead to kidney damage, this approval will allow patients in China access to a new treatment option to help slow the progressive nature of systemic lupus.”
The NMPA approval is based on data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) phase III trial, which showed that over two years, belimumab added to standard therapy increased renal response rates and helped to reduce the risk of worsening of kidney disease in patients with active LN compared to standard of care 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.”
The BLISS-LN phase III trial is the largest and longest trial conducted in active LN, involving 448 adult patients. The trial met its primary endpoint, demonstrating that a statistically significant and clinically meaningful greater number of patients achieved Primary Efficacy Renal Response (PERR) at two years (or 104 weeks) when treated with belimumab plus standard of care compared to placebo plus standard of care in adults with active LN (43% vs 32%, odds ratio (95% CI) 1.55 (1.04, 2.32), p=0.0311). Statistical significance compared to placebo across all four major secondary endpoints was achieved, including complete renal response at week 104 and time to renal-related event or death. The adverse reactions observed in BLISS-LN were consistent with the known safety profile of belimumab administered intravenously plus standard of care in patients with SLE.
Belimumab is also approved in China for five-year-old and older patients with active, autoantibody-positive SLE with high disease activity (e.g., positive anti-double-stranded DNA and low complement, and an objective assessment of overall disease activity using SELENA-SLEDAI score ≥ 8) in combination with standard of care. It is also the first biologic in China’s 2021 National Reimbursement Drug List for paediatric SLE.
About the BLISS-LN trial
BLISS-LN is a phase III, 104-week, randomised, double-blind, placebo-controlled, post-approval commitment trial to evaluate the efficacy and safety of intravenous (IV) belimumab 10mg/kg plus standard of care (mycophenolate mofetil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids) compared to placebo plus standard of care in adult patients with active LN. Active LN was confirmed by renal biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society criteria within the past six months, and clinically active kidney disease requiring induction therapy.[i]
The most common form of lupus is SLE, a chronic, incurable, autoimmune disease. It is difficult to diagnose and even more challenging to treat. The condition is associated with a range of debilitating symptoms that can fluctuate over time, including painful or swollen joints, extreme fatigue, unexplained fever, and skin rashes. In LN, SLE causes inflammation (swelling or scarring) of the small blood vessels that filter wastes in the kidney (glomeruli) and sometimes the kidneys by attacking them like they would attack a disease.[ii] LN can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. Despite improvements in diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis.[iii],[iv] Manifestations of LN include proteinuria, elevated serum creatinine levels, and urinary sediment. Approximately 20% of patients with LN progress to end-stage kidney disease within ten years of diagnosis.[v]
About Benlysta (belimumab)
Benlysta (belimumab), a B-lymphocyte stimulator (BLyS) specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. Belimumab does not bind to B cells directly or directly deplete B cell populations. By binding BLyS, belimumab inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
In China, belimumab was approved for add-on treatment of adults with SLE as an IV formulation in July 2019 and for children aged five years and above in December 2020.
Benlysta China Indication
Benlysta, combined with standard therapy, is indicated as therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high disease activity (e.g., positive anti-dsDNA and low complement, SELENA-SLEDAI score≥8) despite standard therapy.
Benlysta, combined with standard therapy, is indicated in adult patients with active lupus nephritis.
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