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FDA approves Krystexxa injection co-administered with methotrexate to help more people with uncontrolled gout achieve a complete response to therapy.-

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Published:9th Jul 2022

Horizon Therapeutics plc announced that the 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 H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. “Immunomodulatory therapies like methotrexate are often used with biologics to reduce the development of anti-drug antibodies and allow more patients to achieve a complete response. 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.”

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).

Condition: Gout
Type: drug

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