March 26, 2021: “GlaxoSmithKline plc announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the use of intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN).
The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission.
If approved, Benlysta would become the first and only biologic approved for both Systemic Lupus Erythematosus (SLE) and LN in the European Union.
This CHMP opinion follows the recent label expansion by the US Food and Drug Administration to include LN.
Christopher Corsico, Senior Vice President, Development, GSK, said: “Active lupus nephritis occurs in more than 1 million patients with systemic lupus erythematosus worldwide.
It causes inflammation in the kidneys and can lead to end-stage kidney disease which may require dialysis or a transplant.
The CHMP’s positive opinion brings us one step closer to providing physicians and patients in Europe with the first treatment option specifically designed to work in lupus and lupus nephritis.”
The CHMP opinion is based on data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study and the unmet need in this patient population.
The BLISS-LN study is the largest and longest phase 3 study conducted in active LN, involving 448 adult patients.
The study met its primary endpoint demonstrating that a statistically significant greater number of patients achieved Primary Efficacy Renal Response 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%, odds ratio (95% CI) 1.55 (1.04, 2.32), p=0.0311).
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.
The adverse reactions observed in BLISS-LN were consistent with the known safety profile of Benlysta administered intravenously plus standard therapy in patients with SLE.
About the BLISS-LN study
BLISS-LN is a phase 3, 104-week, randomised, double-blind, placebo-controlled, post-approval commitment study to evaluate the efficacy and safety of intravenous (IV) belimumab 10 mg/kg plus standard therapy (mycophenolate mofetil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids) compared to placebo plus standard therapy in adult patients with active LN.
Active LN was confirmed by renal biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society criteria within the past 6 months, and clinically active kidney disease requiring induction therapy.
About lupus nephritis
Systemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage.
In lupus nephritis (LN), SLE causes inflammation (swelling or scarring) of the small blood vessels that filter wastes in the kidney (glomeruli) and sometimes the kidneys, by attacking them like they would attack a disease.
LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant.
Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis.
Manifestations of LN include proteinuria, elevations in serum creatinine and the presence of urinary sediment.
Approximately 20% of patients with LN progress to end-stage kidney disease within 10 years of diagnosis.
About Benlysta (belimumab)
Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS.
Belimumab does not bind to B cells directly or directly deplete B cell populations.
By binding BLyS, belimumab inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Belimumab was approved as an IV formulation in July 2011, and as a subcutaneous (SC) formulation in adults in November 2017.”
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-chmp-positive-opinion-recommending-approval-of-benlysta-for-adult-patients-with-active-lupus-nephritis/
