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Horizon Therapeutics: FDA Approves Expanded Labeling For KRYSTEXXA With Methotrexate

Horizon Therapeutics plc (HZNP) announced the FDA has approved the supplemental Biologics License Application expanding the labeling to include KRYSTEXXA injection co-administered with methotrexate, for adults living with uncontrolled gout. The expanded labeling for KRYSTEXXA with methotrexate is based on the results from the MIRROR randomized controlled trial.

"We anticipate this approval will encourage more physicians to recommend KRYSTEXXA with methotrexate to help their patients with uncontrolled gout receive the full benefits of KRYSTEXXA," said Elizabeth Thompson, executive vice president, research and development, Horizon.

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