The FDA approval is based on the positive results of the BLISS-LN study, and the prevalent unmet medical need in the patient population
GSK gets FDA approval for Benlysta. (Credit: Riki Risnandar from Pixabay.)
GlaxoSmithKline (GSK) has secured the US Food and Drug Administration (FDA) approval for its Benlysta (belimumab) to treat active lupus nephritis (LN) in adults, who are receiving standard therapy.
Lupus nephritis is a severe form of kidney inflammation, caused by systemic lupus erythematosus (SLE), and may progress to end-stage kidney disease, which needs dialysis or a kidney transplant.
SLE is associated with symptoms including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage, and they fluctuate over time.
Benlysta is a human monoclonal antibody that specifically binds to soluble BLyS, to inhibit the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
The drug was initially approved in 2011, for both SLE and LN in the US. The current approval extends the same indication to include both intravenous and subcutaneous formulations, said the company.
GSK chief scientific officer and R&D president Hal Barron said: “Approximately 40% of patients with systemic lupus erythematosus develop lupus nephritis, which causes inflammation in the kidneys and can lead to end-stage kidney disease.
“Benlysta is the first medicine approved to treat systemic lupus and adults with active lupus nephritis, an important treatment advance for patients with this incurable autoimmune disease.”
The FDA approval follows a Breakthrough Therapy Designation and Priority Review and is based on the positive results of the BLISS-LN study, and the prevalent unmet need in the patient population.
BLISS-LN is a phase 3, 104-week, randomised, double-blind, placebo-controlled, post-approval commitment study, in 448 adult patients.
The study evaluated the efficacy and safety of intravenous (IV) Benlysta 10mg/kg plus standard therapy versus placebo plus standard therapy in adult patients with active LN.
Standard therapy includes mycophenolate mofetil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids.
In the study, the treatment with Benlysta plus standard therapy has met the primary endpoint, showing a statistically significant number of patients achieved Primary Efficacy Renal Response (PERR), when compared to placebo plus standard therapy.
Also, the study achieved statistical significance across all four major secondary endpoints, including complete renal response and time to renal-related event or death.
The company said that BLISS-LN is the largest and longest phase 3 study ever conducted in active LN, and showed consistent safety results with the known safety profile of Benlysta.
BLISS-LN study lead investigator Richard Furie said: “We have long aspired to enhance outcomes for patients with lupus nephritis.
“In the four decades I have been caring for people with lupus, we have not been able to achieve remission in more than just 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 not only increased response rates over two years, but it also prevented worsening of kidney disease in patients with active lupus nephritis compared to standard therapy alone. Therefore, it is gratifying to see the rewards of decades of research.”