| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 8342985 | Molecular Genetics and Metabolism | 2018 | 12 Pages |
Abstract
Results from the PRISM Phase 3 program support the efficacy of pegvaliase for the treatment of adults with PKU, with a manageable safety profile in most participants. The PRISM-2 extension study will continue to assess the long-term effects of pegvaliase treatment.
Keywords
PHECTCAESAEMedDRATABISRACMGPKUNaBRDTPALRDAPAHDMCNIAID/FAANphenylketonuriaPOMsNeutralizing antibodiesstandard deviationimmunoglobulin ITTHAEMedical Dictionary for Regulatory ActivitiesRecommended dietary allowanceadverse eventSerious adverse eventPhenylalanine ammonia lyasePhenylalanine hydroxylasePhenylalanineIntent-to-treatProfile of Mood StatesCommon Terminology Criteria for Adverse EventsPrismpolyethylene glycolPEGAmerican College of Medical Genetics and GenomicsData Monitoring Committee
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Authors
Janet Thomas, Harvey Levy, Stephen Amato, Jerry Vockley, Roberto Zori, David Dimmock, Cary O. Harding, Deborah A. Bilder, Haoling H. Weng, Joy Olbertz, Markus Merilainen, Joy Jiang, Kevin Larimore, Soumi Gupta, Zhonghua Gu, Hope Northrup,