GlaxoSmithKline plc 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.