GSK Receives FDA Approval for Chronic Disease Treatment

GSK recently announced that FDA approved BENLYSTA (belimumab) as the first chronic disease treatment for adult patients with lupus nephritis (LN), who are receiving standard therapy. 

Specifically, the approval extends FDA’s 2019 approval to include both LN and systemic lupus erythematosus (SLE). The latest approval also cover both the intravenous and subcutaneous formulations of the treatment.

LN is a serious inflammation of the kidneys caused by SLE, the most common form of lupus that can lead to end-stage kidney disease. This generally requires dialysis or kidney transplant.  

Benlysta is indicated for patients five years of age and older with active, autoantibody-positive systemic SLE who are receiving standard therapy, as well as for patients 18 years of age and older with active LN who are receiving standard therapy. 

But the drug is not recommended in patients with severe active central nervous system lupus or in combination with other biologics, GSK noted. 

“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,” Gal Barron, MD, chief scientific officer and president of R&D at GSK, said in the announcement. 

“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,” Barron continued.

The FDA approval builds on AstraZeneca’s nearly 10 years of experience in lupus and follows Breakthrough Therapy Designation and Priority Review.

Specifically, FDA based its decision on the overall unmet need in the patient population and positive results from the BLISS-LN study 

The Phase 3 study enrolled 448 patients with active LN and found that a greater number of patients achieved primary efficacy renal response at two years when treated with Benlysta plus standard therapy compared to a placebo plus standard therapy.

The treatment also achieved statistically significance across all four major secondary endpoints, including complete renal response and time to renal-related events or death, compared to a placebo, GSK explained.

Additionally, drug safety results were consistent with the known safety profiles. 

“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,” said Richard Furie, MD, chief of the division of rheumatology, professor at the Feinstein Institutes for Medical Research at Northwell Health, and lead investigator of the BLISS-LN study.

“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,” Furie continued. 

Brad Rovin, MD, director of the division of nephrology and medical director of the center for clinical research management at the Ohio State University Wexner Medical Center also emphasized that the main goal in managing patients with LN is to delay the need for dialysis and transplantation. 

“The addition of BENLYSTA to standard therapy showed that patients had a 49% decrease in risk for experiencing a renal-related event. I’m encouraged by the progress we’re making in lupus nephritis,” Rovin continued. 

Although there is currently no known cure for lupus, many researchers continue to work to develop potential treatment options for patients living with the disease.

At the beginning of July, researchers from Children’s Hospital of Pennsylvania (CHOP) leveraged a new genome mapping approach to uncover two new possible therapies for lupus. 

Through the mapping, researchers found two kinases, HIPK1 and MINK1, which previously had no known role in lupus. When these enzymes are targeted in follicular helper T cells, they inhibit the production of interleukin-21, a cytokine that’s involved in regulating antibody production, researchers stated. 

Because of these positive findings, experts are planning to develop HIPK1 transgenic mouse models to study their sensitivity to experimental lupus and the potential impact of HIPK1 on antiviral immunity.