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The EC’s approval of GSK’s Benlysta (belimumab) marks the first and only biologic approved for both systemic lupus erythematosus and lupus nephritis.
On May 5, 2021, GlaxoSmithKline (GSK) announced that the European Commission (EC) approved the expanded use of intravenous (IV) and subcutaneous (SC) Benlysta (belimumab), in combination with background immunosuppressive therapies, for treating active lupus nephritis (LN) in adults in Europe, in addition to systemic lupus erythematosus (SLE). This marketing authorization follows the recent approval for the similar expanded LN indication in the United States, GSK stated in a company press release.
The marketing authorization application was based on data from a study that showed belimumab, over two years, added to increased renal response rates with standard therapy and helped to prevent worsening of kidney disease in patients with active LN compared to standard therapy alone.
Benlysta is a BLyS-specific inhibitor human monoclonal antibody (mAb) that binds to soluble BLyS. By binding BLyS, the mAb inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Belimumab was first approved in the European Union in July 2011 for use as an add-on IV therapy in adults with SLE and as a SC formulation in November 2017. The SLE indication was extended for the use in children for the IV formulation in October 2019.
“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 [one] 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,” said Hal Barron, chief scientific officer and president R&D, GSK, in the press release.
“In the [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 [prior event rate ratio]. 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,” said Y.K.O. (Onno) Teng, MD, PhD, Nephrology clinician-scientist at the Department of Internal Medicine of the Leiden University Medical Center, The Netherlands, in the press release.
“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 [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,” added 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 study, in the press release.