[{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Horizon Therapeutics plc Submits Supplemental Biologics License for the Concomitant Use of KRYSTEXXA\u00ae (pegloticase injection) Plus Methotrexate for People Living with Uncontrolled Gout","therapeuticArea":"Rheumatology","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Horizon Therapeutics plc Announces FDA Has Granted Priority Review of the Supplemental Biologics License Application (sBLA) for the Concomitant Use of KRYSTEXXA\u00ae (pegloticase injection) Plus Methotrexate for People Living With Uncontrolled Gout","therapeuticArea":"Rheumatology","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Horizon Therapeutics plc to Present MIRROR Randomized Controlled Trial Primary Endpoint Data at The EULAR 2022 European Congress of Rheumatology","therapeuticArea":"Rheumatology","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Data Presented from the MIRROR Randomized Controlled Trial Demonstrate KRYSTEXXA\u00ae (pegloticase injection) Plus Methotrexate Resulted in Significant Improvement in Efficacy and Safety (Infusion Reactions) Compared to KRYSTEXXA Monotherapy","therapeuticArea":"Rheumatology","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sustained Patient Response to KRYSTEXXA\u00ae (pegloticase) Injection with Methotrexate Compared to KRYSTEXXA Alone Shown through Month 12 in MIRROR Randomized Controlled Trial","therapeuticArea":"Rheumatology","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"}]
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The co-administration of KRYSTEXXA (pegloticase) with an immunomodulator like methotrexate has increasingly been employed in patients with uncontrolled gout to help reduce the development of antidrug antibodies, which can affect treatment efficacy with biologics.
The MIRROR randomized controlled trial outcomes provided a clear view of improvements in patient response and reductions in infusion reactions for KRYSTEXXA plus low-dose (15 mg/week) methotrexate compared to KRYSTEXXA plus placebo.
KRYSTEXXA® (pegloticase injection) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Application based on recent MIRROR randomized controlled trial results, which showed 71% of patients randomized to receive KRYSTEXXA (pegloticase), a PEGylated uric acid specific enzyme plus methotrexate achieved a complete response.
sBLA Submission based on recent results from the MIRROR randomized clinical trial, which showed a 71% response rate for patients randomized to receive KRYSTEXXA (Pegloticase) PEGylated uric acid specific enzyme, plus methotrexate for people living with uncontrolled Gout.