Horizon nabs FDA expanded label for gout med Krystexxa
Horizon Therapeutics landed an expanded label for gout med Krystexxa on Thursday with the FDA approval for the addition of methotrexate. Krystexxa plus methotrexate now will be the recommended and preferred dose for most patients.
That’s because the combination significantly reduces an immune system’s anti-drug antibody reaction. Horizon’s MIRROR randomized controlled trial, begun in 2019 with results out last December, showed a more than 30 percentage point increase in patient response with the combined med. Seventy-one percent of patients who received Krystexxa with methotrexate met the study endpoints of lower than 6mg/dL serum uric acid at six months versus just 39% of patients on Krystexxa with placebo. Patients in the study maintained improved results through one year of treatment with 60% achieving complete response versus 31% on placebo.
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