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Savient Reports Krystexxa Study Results Which Reinforce Health-Related Quality of Life Benefit

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Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced results from new post-hoc analyses of KRYSTEXXA^® (pegloticase) pivotal Phase III and open-label extension trials that reinforced the health-related quality of life (HRQOL) benefits of KRYSTEXXA treatment in adult patients with refractory chronic gout (RCG), including tophus reduction outcomes. New data also demonstrated that guidance on measuring serum uric acid (sUA) levels as a biomarker of therapeutic response and infusion reaction (IR) risk significantly reduced the rate of IRs in the post-approval setting, as compared to rates seen during randomized clinical trials. These data will be presented this week at the American College of Rheumatology/Associate Rheumatology Health Professional (ACR/ARHP) Annual Meeting this week, November 9-14, 2012.

An analysis examining relative risk of IRs with KRYSTEXXA during a defined post-approval period (September 2010 – September 2012) supported the effectiveness of the clinical guidance contained in the current U.S. label designed to identify patients at potentially higher risk for IRs by monitoring sUA response and discontinuing treatment if levels increase to above 6 mg/dL, particularly when two consecutive levels above 6 mg/dL are observed. The analysis showed that there was an approximate two-thirds reduction in the incidence of IRs in the post-approval period compared to the rate seen in the randomized clinical trials where there was no clinical guidance in effect.

In another analysis, researchers observed sustained patient-reported HRQOL improvements among participants identified as responders during their first six months of treatment in the six-month, randomized, placebo-controlled Phase III trials for an additional two-and-a-half years when treated with KRYSTEXXA 8 mg every two weeks during open-label extension study. These outcomes were measured through widely-utilized assessment tools, including Medical Outcomes Study Short Form-36 (SF-36) physical component summary scores and the Health Assessment Questionnaire-Disability Index (HAQ-DI).

Posted-In: News FDA

 

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