GSK’s Benlysta Approved for Pediatric Patients With Lupus Nephritis

The FDA has expanded its approval of GSK’s Benlysta (belimumab) for pediatric patients with active lupus nephritis between the ages of five and 17 who are receiving standard therapy.

The monoclonal antibody, which is approved in intravenous and subcutaneous forms, works by inhibiting B cell activating factor.

Benlysta was first approved by the FDA in March 2011 for the treatment of systemic lupus erythematosus, the most common type of lupus. It was approved for lupus nephritis in December 2020.

The approval provides another treatment option for pediatric patients, who were previously given non-selective immunosuppressants and corticosteroids, the company said.