GSK Says FDA Approves Kidney Disease Drug for Children

Signage outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. (Andrew Kelly/Reuters)

GSK Plc. said on Wednesday the Food and Drug Administration (FDA) had cleared its kidney disease drug Benlysta for the treatment of children aged 5–17 years.

The clearance makes Benlysta the first treatment approved by the U.S. regulator for children with lupus nephritis, a kind of kidney inflammation.

Lupus nephritis is a complication of an autoimmune disease called lupus, which could lead to kidney damage and failure.

Benlysta in 2020 received approval in the United States for adult patients with the disease.