HZNP - Horizon gets FDA approval for Krystexxa's use with methotrexate for uncontrolled gout

• The U.S. Food and Drug Administration (FDA) approved Horizon Therapeutics' ( NASDAQ: HZNP ) application seeking expanded approval of Krystexxa (pegloticase) injection for use with immunosuppressant drug methotrexate for uncontrolled gout.
• Krystexxa was already approved indicated for treating chronic gout (a type of arthritis) in adult patients resistant to conventional therapies. Uncontrolled gout occurs when a person experiences high uric acid levels, even while taking gout medication.
• In March, the FDA had granted priority review to Horizon's supplemental biologics license application seeking label expansion for Krystexxa plus methotrexate.
• The current approval was based on data from a study called MIRROR.

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