GSK’s Benlysta treatment, for patients with active lupus nephritis (LN) in addition to systemic lupus erythematosus (SLE), has been approved by the European Commission for expanded use.
Benlysta can now be used in combination with background immunosuppressive therapies for the treatment of adult patients with active LN, in addition to SLE. The EU marketing authorisation follows recent approval for the similar expanded LN indication in the US.
SLE, the most common form of lupus, is a chronic, incurable, autoimmune disease. The condition is associated with a range of debilitating symptoms that can fluctuate over time, including painful or swollen joints, extreme fatigue, unexplained fever, and skin rashes. SLE can cause LN, which in turn can lead to end-stage kidney disease.
The decision follows the BLISS-LN Phase III study, involving 448 patients with active LN. The trial found that a statistically significant greater number of participants on Benlysta with standard care achieved Primary Efficacy Renal Response (PERR) at two years (43%), as opposed to those on placebo (32%).
Statistical significance compared to placebo across all four major secondary endpoints was achieved.
The study showed that Benlysta, added to standard therapy, increased renal response rates and helped to prevent worsening of kidney disease in patients with active LN compared to standard therapy alone.
Dr Hal Barron, Chief Scientific Officer and President R&D at GSK, said: “Active lupus nephritis, which causes inflammation in the kidneys, is one of the most serious consequences of SLE 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.”
Dr Richard Furie, Chief of the Division of Rheumatology at the Feinstein Institutes for Medical Research at Northwell Health, and Lead Investigator of the BLISS-LN study, added: “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.”
Jack Goddard
This is a syndicated feed from Pharmafile
