FDA Approves KRYSTEXXA® (pegloticase) Injection Co-Administered With Methotrexate, Expanding the Labeling to Help More People with Uncontrolled Gout Achieve a Complete Response to Therapy
— Approval based on MIRROR randomized controlled trial, which showed significant improvement and sustained patient response to KRYSTEXXA with methotrexate compared to KRYSTEXXA alone — — Trial data showed a greater than 30 percentage-point increase in efficacy, and a significant reduction in infusion reactions from 31% to 4% — — Priority review was granted for … [Read more…]
