Horizon Therapeutics (Nasdaq: HZNP) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) expanding the labeling to include KRYSTEXXA (pegloticase) injection co-administered with methotrexate, which will help more people with uncontrolled gout achieve a complete response to therapy.
The expanded labeling for KRYSTEXXA with methotrexate is based on the results from the MIRROR randomized controlled trial in which adults living with uncontrolled gout were randomized to receive methotrexate (15 mg/week) or placebo for four weeks, and then treatment with KRYSTEXXA with methotrexate or KRYSTEXXA with placebo for 52 weeks. The primary endpoint was defined as the proportion of serum uric acid (sUA) responders during Month 6 (defined as sUA less than 6 mg/dL at least 80% of the time).
