GSK Says FDA Approves Kidney Disease Drug for Children

By Reuters
July 29, 2022 Updated: July 29, 2022

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.