HZNP - Horizon Therapeutics gets FDA priority review for Krystexxa combo for uncontrolled gout

The U.S. Food and Drug Administration (FDA) granted priority review to Horizon Therapeutics' (NASDAQ:HZNP) biologics license application to expand the label for Krystexxa plus methotrexate. The FDA is expected to make a decision by July 7. Krystexxa is indicated for treating chronic gout (a type of arthritis) in adult patients resistant to conventional therapies, also known as uncontrolled gout. Uncontrolled gout occurs when a person experiences high uric acid levels, even while taking gout medication. The company said data suggested that treatment with Krystexxa in combination with methotrexate can help to prevent anti-drug antibodies, helping more patients achieve a durable response to therapy. The application was backed by data which showed that 71 of 100 patients who received KRYSTEXXA plus methotrexate achieved a complete serum uric acid response, at least 80% of the time during month 6.

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Horizon Therapeutics gets FDA priority review for Krystexxa combo for uncontrolled gout