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EU Commission Approves Benlysta for Lupus Nephritis

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European Commission Approves Benlysta for Adult Patients with Active Lupus Nephritis | Pharmtech Focus

GlaxoSmithKline plc (GSK) today announced the European Commission has approved the expanded use of intravenous and subcutaneous BENLYSTA (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN) in Europe, in addition to systemic lupus erythematosus (SLE). The EU marketing authorisation follows the recent approval for the similar expanded LN indication in the U.S.

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK said: “Active lupus nephritis, which causes inflammation in the kidneys, is one of the most serious consequences of systemic lupus erythematosus and occurs in more than 1 million patients worldwide. Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with this complex autoimmune disease.”

The marketing authorisation application was based on data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study, which showed that, over two years, belimumab added to standard therapy increased renal response rates and helped to prevent worsening of kidney disease in patients with active lupus nephritis compared to standard therapy alone.

The BLISS-LN study is the largest and longest phase 3 study conducted in active LN, involving 448 adult patients. The study met its primary endpoint demonstrating that a statistically significant greater number of patients achieved Primary Efficacy Renal Response (PERR) at two years (or 104 weeks) when treated with belimumab plus standard therapy compared to placebo plus standard therapy 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 therapy in patients with SLE.

Dr. Y.K.O. (Onno) Teng, MD, PhD, Nephrology clinician-scientist at the Department of Internal Medicine of the Leiden University Medical Center (LUMC), The Netherlands said: “In the BLISS-LN study the addition of Benlysta to standard therapy resulted in a 49% decrease in risk to patients of experiencing a renal-related event as well as a significantly higher number of study participants reaching the PERR. I’m encouraged that progress is being made for people with lupus nephritis as we work toward the overarching goal to delay the need for kidney replacement therapies, such as dialysis and transplantation.”

Dr. Richard Furie, Chief of the Division of Rheumatology and Professor at the Feinstein Institutes for Medical Research at Northwell Health, and Lead Investigator of the BLISS-LN study commented“This achievement is derived from decades of research. For years, we have not been able to achieve remission for more than one-third of patients with lupus nephritis and, despite all of our efforts, 10% to 30% of patients with lupus kidney disease still progress to end-stage kidney disease. The data from the BLISS-LN study show that Benlysta added to standard therapy in management of active lupus nephritis may lead to improved long-term outcomes for patients by both increasing response rates and delaying further kidney disease progression.”

GSK’s commitment to immunology
GSK is focused on the research and development of medicines for immune-mediated diseases, such as lupus and rheumatoid arthritis, that are responsible for a significant health burden to patients and society. Our world-leading scientists are focusing research on the biology of the immune system with the aim to develop immunological-based medicines that have the potential to alter the course of inflammatory disease. As the only company with a biological treatment approved for adult and pediatric lupus, GSK is leading the way to help patients and their families manage this chronic, inflammatory autoimmune disease. Our aim is to develop transformational medicines that can alter the course of inflammatory disease to help people live their best day, every day.

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