FDA approves sBLA for Krystexxa

Horizon Therapeutics (Nasdaq: HZNP) has announced that the US 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.

“Today’s approval for Krystexxa with methotrexate is the culmination of more than five years of effort and demonstrates Horizon’s commitment to working together with the gout community to improve the patient experience and outcomes,” said Elizabeth Thompson, executive vice president, research and development, Horizon. “Immunomodulatory therapies like methotrexate are often used with biologics to reduce the development of anti-drug a

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