GSK’s Benlysta (Belimumab) Approved in China for Active Lupus Nephritis in Adults

News on February 14, 2022 /BioValleyBIOON/ --GlaxoSmithKline PLC.(GSK) recently announced that the National Medical Products Administration (NMPA) of China has approved Benlysta (Belimumab, trade name: 倍力腾): for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard care. Previously, Benlysta had been approved: as an add-on therapy for the treatment of active systemic lupus erythematosus in patients aged 5 years and older.Lupus Erythematosus(SLE) pediatric and adult patients.This latest approval makes Benlysta the first and only biologic approved in China for the treatment of LN in SLE.

GSK Chief Scientific Officer and R&D President Hal Barron stated: "In China, nearly 500,000 people suffer from systemicSystemic Lupus Erythematosus, more than half of the patients may develop one of the most common and severe complications, lupus nephritis. Recognizing that lupus nephritis can lead to kidney damage, this approval will provide Chinese patients with a new treatment option to help slow the progression of systemic lupus erythematosus."

This approval is based on data from the Phase 3 BLISS-LN study. The study was conducted in adult patients with active LN, and the data showed:During the 2-year treatment period, compared with standard therapy, Benlysta combined with standard therapy increased renal response rates in patients with active LN, reduced the risk of renal disease worsening, and improved long-term patient outcomes.

LN is a type of kidney inflammation caused by SLE, which can lead to end-stage kidney disease (ESKD) and may require dialysis or kidney transplantation. Worldwide, more than 1 million SLE patients develop active LN. LN is one of the most common and severe complications of SLE, occurring in up to 40% of SLE patients, causing kidney inflammation and potentially leading to end-stage kidney disease.

Notably, in January 2021, the U.S. FDA approved Aurinia Pharmaceuticals' oral novel best-in-class calcineurin inhibitor Lupkynis (voclosporin), in combination with background immunosuppressive therapy, for the treatment of adult patients with active LN. This approval made Lupkynis the first...FDAThe first approved oral therapy for the treatment of LN.

BLISS-LN is the largest and longest trial conducted in patients with active LN. This is a 2-year (104-week) randomized, double-blind, placebo-controlled post-marketing commitment study, enrolling a total of 448 patients. It evaluated the efficacy and safety of Benlysta (intravenous infusion [IV], 10mg/kg) combined with standard therapy (mycophenolate mofetil for induction and maintenance, or cyclophosphamide induction and azathioprine maintenance, plus corticosteroids) and placebo combined with standard therapy in adult patients with active LN. Active LN was confirmed during the screening visit by renal biopsy and clinically active kidney disease according to the 2003 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria.

The primary endpoint of the study is the Primary Efficacy Renal Response (PERR), defined as: estimated glomerular filtration rate (eGFR) ≥60ml/min/1.73m2, or no more than a 20% decline in eGFR from pre-flare levels; urine protein-to-creatinine ratio (uPCR) ≤0.7; and not being a treatment failure. The most stringent secondary endpoint, Complete Renal Response (CRR), is defined as: eGFR declining by no more than 10% from pre-flare values or within the normal range, uPCR <0.5, and not being a treatment failure. Ordered Renal Response (ORR) is defined as complete, partial, or no response.

The results showed,The study met the primary endpoint: after 2 years of treatment, a statistically significant increase in the number of patients achieving PERR was observed in the Benlysta + standard therapy group compared to the placebo + standard therapy group (43% vs 32%, odds ratio [95% CI] = 1.55 [1.04, 2.32], p = 0.0311). Additionally, Benlysta demonstrated statistical significance over placebo across four key secondary endpoints, including: complete renal response (CRR, the most stringent measure of renal response) after 2 years, ordered renal response (ORR) after 2 years, PERR after 1 year, and time to death or renal-related events.In the study, the safety outcomes of the Benlysta + standard therapy group were generally comparable to those of the placebo + standard therapy group. The safety results were consistent with the known profile of Benlysta.

SystematicSystemic Lupus Erythematosus(SLE) is the most common type of lupus (accounting for about 70%), which is a chronic, incurableAutoimmunitySexual diseases, accompanied by a series of symptoms that fluctuate over time, including joint pain or swelling, extreme fatigue, unexplained fever, rash, and organ damage. In lupus nephritis (LN), systemicSystemic Lupus Erythematosus(SLE) causes kidney inflammation, which can lead to end-stage renal disease. Despite progress in recent decades, LNDiagnosisBoth have improved, but it remains an indicator of poor prognosis. The manifestations of LN include proteinuria, elevated serum creatinine, and the presence of urinary sediment.

Benlysta is the first specific inhibitor of B lymphocyte stimulator (BLyS), capable of blocking the binding of soluble BLyS (a B-cell survival factor) to the BLyS receptor on B cells. Benlysta does not directly bind to B cells but by binding to BLyS, it inhibits the survival of B cells (including autoreactive B cells) and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Benlysta can reduce the number of abnormal B lymphocytes that exacerbate the condition of lupus patients; these abnormal B lymphocytes cause the immune system to erroneously attack blood vessels and other healthy tissues in the body, leading to lupus and other autoimmune diseases.

As the world's first biologic approved for the treatment of SLE, Benlysta (Belimumab for Injection) has been approved in China for use in combination with standard therapy, applicable to: pediatric and adult patients aged ≥5 years with active, autoantibody-positive SLE who still exhibit high disease activity despite standard therapy.

Since Benlysta was approved for adult SLE indication in China in July 2019, it received approval for pediatric SLE indication (patients aged 5 years and above) in December 2020. Both indications were included in the medical insurance in the second year after approval, making Benlysta the first and only biologic agent in China that can be reimbursed by medical insurance for the treatment of both pediatric and adult SLE. (Bioon.com)

Source of the original text:China’s National Medical Products Administration approves Benlysta (belimumab) for adult patients with active lupus nephritis