GlaxoSmithKline plc (Gsk) announced today that the European Commission has approved the extended use of intravenous and subcutaneous Benlysta * (belimumab) in combination with basic immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (Ln) in Europe, in addition to systemic lupus erythematosus (Les. The EU marketing authorization follows the recent approval for the similar extended indication of Ln in the United States. “Active lupus nephritis, which causes inflammation of the kidneys – recalls Hal Barron, scientific director and president of R&D GSK – is one of the most serious consequences of systemic lupus erythematosus and occurs in more than 1 million patients worldwide. Benlysta is the first biological drug approved for the treatment of lupus and nephritis lupus, representing a significant new treatment option for patients and doctors across Europe dealing with this complex autoimmune disease “. nda of the marketing authorization was based on data from the Bliss-Ln study which demonstrated over two years that belimumab, added to standard therapy, increased renal response rates and helped prevent worsening of renal disease in patients. with active lupus nephritis compared to standard therapy alone. This is the largest and longest phase 3 study conducted on Ln, involving 448 adult patients. “In the Bliss-LN study, the addition of Benlysta to standard therapy – comments YKO (Onno) Teng, clinical scientist of Nephrology at the Department of Internal Medicine at Leiden University Medical Center, The Netherlands – produced a 49% reduction in risk. for patients to experience a kidney-related event, as well as significantly more study participants who achieve the “Perr” (primary efficacy renal response). “I am encouraged that progress is being made for people with lupus nephritis as we work towards the overall goal of delaying the need for kidney replacement therapies, such as dialysis and transplantation.” “This result comes from decades of research. For years, we have not been able to achieve remission for more than a third of patients with lupus nephritis, and despite all our efforts, 10-30% of patients with lupus kidney disease still progress to end-stage kidney disease. . The data from the Bliss-Ln study – comments Richard Furie, head of the Division of Rheumatology and professor at the Feinstein Institutes for Medical Research at Northwell Health, and lead researcher of the study – show that Benlysta added to standard therapy in the management of active lupus nephritis can lead to better long-term outcomes for patients by both increasing response rates and delaying further progression of kidney disease. “
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