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.
Horizon Therapeutics
Horizon Therapeutics plc is a biopharmaceutical company focused on researching, developing, and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Horizon primarily markets products in the United States, which represented 97% of Horizon's 2019 worldwide sales. In 2014 Horizon executed a tax inversion to move its legal headquarters to Ireland to avail of Ireland's low tax rates and beneficial corporate tax system. On May 2, 2019, shareholders of the company approved the change of the company's name to Horizon Therapeutics plc.
July 14, 2022
