EC clears GSK's Benlysta for lupus nephritis

The European Commission approved expanded use of GlaxoSmithKline’s intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for adults with active lupus nephritis (LN).

The drug is already on the market to treat systemic lupus erythematosus (SLE); this latest approval now provides physicians and patients in Europe with the first and only biologic treatment specifically designed to work in lupus and LN.

“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,” noted Dr Hal Barron, GSK's chief scientific officer and president R&D.

“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 drug's marketing submission was based on data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study, which showed that when added to standard therapy Benlysta increased renal response rates and helped to prevent worsening of kidney disease in patients with active lupus nephritis versus standard therapy alone.

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%).

Also, 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.

“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,” commented Dr Y.K.O. (Onno) Teng, Nephrology clinician-scientist at the Department of Internal Medicine of the Leiden University Medical Center (LUMC), The Netherlands.

“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.”