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Horizon’s Krystexxa (pegloticase) Receives the US FDA’s Approval and Expanding the Labeling for the Treatment of Uncontrolled Gout

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Horizon’s Krystexxa (pegloticase) Receives the US FDA’s Approval and Expanding the Labeling for the Treatment of Uncontrolled Gout

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  • The approval was based on the (MIRROR) trial evaluating Krystexxa + methotrexate vs Krystexxa & PBO in a ratio (2:1) in 152 adults with uncontrolled gout for 52wks.
  • The results showed a 30% point increase in patient response rate during 6 & 12mos., 71% vs 39% of patients achieved the 1EPs @6mos., 60% vs 31% achieved a complete response @12mos., 4% vs 31% experienced infusion reactions with no new safety signals, 22%-point increase in the complete resolution of one tophus @12mos. 54% vs 31% had complete resolution of one tophus, no new tophus and no single tophus showed progression @52wk.
  • Additionally, the patients treated with Krystexxa achieved a 32% point improvement in treatment response rate with 71% vs 39% achieved a sustained urate-lowering response @6mos. 

Ref: Horizon | Image: Horizon

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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