Horizon’s Krystexxa Approved for Treating Uncontrolled Gout

The FDA has approved Horizon Therapeutics’ supplemental Biologics License Application (sBLA) for its injectable drug, Krystexxa (pegloticase), coadministered with methotrexate for patients with uncontrolled gout.

Specifically, Krystexxa is indicated for the treatment of chronic gout in adult patients whose symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

In a clinical study, the combined treatment led to significant improvements in patient response rates, a reduction in infusion reactions and complete resolution of at least one tophus, a condition in which uric acid builds up around the joints.