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Clinical Review Karen Bleich NDA 020351 Supplement 44 (CCTA) Visipaque (Iodixanol)

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Clinical Review Karen Bleich NDA 020351 Supplement 44 (CCTA) Visipaque (Iodixanol) Clinical Review Karen Bleich NDA 020351 Supplement 44 (CCTA) Visipaque (iodixanol) CLINICAL REVIEW Application Type Supplemental New Drug Application Application Number(s) NDA 020351 s44 Priority or Standard Priority Submit Date(s) October 6th, 2016 Received Date(s) October 18th, 2016 PDUFA Goal Date April 5th, 2017 Division/Office Division of Medical Imaging Products/Office of Drug Evaluation IV Reviewer Name(s) Karen Bleich, MD Review Completion Date March 10th, 2017 Established Name Iodixanol (Proposed) Trade Name Visipaque Injection Applicant GE Healthcare Formulation(s) 320 mgI/mL Dosing Regimen 70-80 mL main bolus volume (does not include optional test bolus volume of 20 mL) at a flow rate of(b) (4) mL/s, followed by 20 mL saline flush Applicant Proposed For use in coronary computed tomography angiography (CCTA) to Indication(s)/Population(s) assist in the diagnostic evaluation of patients with suspected coronary artery disease. Recommendation on Approval Regulatory Action Recommended For use in coronary computed tomography angiography (CCTA) to Indication(s)/Population(s) assist in the diagnostic evaluation of patients with suspected (if applicable) coronary artery disease. CDER Clinical Review Template 2015 Edition 1 Reference ID: 4068412 Clinical Review Karen Bleich NDA 020351 Supplement 44 (CCTA) Visipaque (iodixanol) Table of Contents Glossary ........................................................................................................................................... 8 1 Executive Summary ............................................................................................................... 10 1.1. Product Introduction ...................................................................................................... 10 1.2. Conclusions on the Substantial Evidence of Effectiveness ............................................ 10 1.3. Benefit-Risk Assessment ................................................................................................ 10 2 Therapeutic Context .............................................................................................................. 13 2.1. Analysis of Condition ...................................................................................................... 13 2.2. Analysis of Current Treatment Options ......................................................................... 13 3 Regulatory Background ......................................................................................................... 14 3.1. U.S. Regulatory Actions and Marketing History ............................................................. 14 3.2. Summary of Presubmission/Submission Regulatory Activity ........................................ 15 3.3. Foreign Regulatory Actions and Marketing History ....................................................... 16 4 Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety................................................................................................................. 16 4.1. Office of Scientific Investigations (OSI) .......................................................................... 17 4.2. Product Quality .............................................................................................................. 17 4.3. Clinical Microbiology ...................................................................................................... 17 4.4. Nonclinical Pharmacology/Toxicology ........................................................................... 17 4.5. Clinical Pharmacology .................................................................................................... 17 4.5.1. Mechanism of Action .............................................................................................. 17 4.5.2. Pharmacodynamics ................................................................................................. 17 4.5.3. Pharmacokinetics .................................................................................................... 18 4.6. Devices and Companion Diagnostic Issues .................................................................... 18 4.7. Consumer Study Reviews ............................................................................................... 18 5 Sources of Clinical Data and Review Strategy ....................................................................... 18 5.1. Table of Clinical Studies .................................................................................................. 18 5.2. Review Strategy .............................................................................................................. 21 6 Review of Relevant Individual Trials Used to Support Efficacy ............................................. 21 CDER Clinical Review Template 2015 Edition 2 Reference ID: 4068412 Clinical Review Karen Bleich NDA 020351 Supplement 44 (CCTA) Visipaque (iodixanol) 6.1. GE-189-002 and Re-read GE-012-101 ............................................................................ 22 6.1.1. Study Design............................................................................................................ 22 6.1.2. Study Results ........................................................................................................... 33 6.2. GE-012-096 “A prospective, multicenter registry study for clinical outcomes in subjects undergoing coronary CTA examination” .................................................................................. 42 6.2.1. Study Design............................................................................................................ 42 6.2.2. Study Results ........................................................................................................... 45 6.3. Supportive Evidence Based on Published Literature ..................................................... 51 6.3.1. Literature Review of Visipaque-Only Studies ......................................................... 51 6.3.2. Literature Review of Major Recent Studies with Multiple Contrast Agents, Including Visipaque ........................................................................................................... 55 7 Integrated Review of Effectiveness ....................................................................................... 58 7.1. Assessment of Efficacy Across Trials .............................................................................. 58 7.1.1. Dose and Dose-Response........................................................................................ 61 7.2. Integrated Assessment of Effectiveness ........................................................................ 61 8 Review of Safety .................................................................................................................... 62 8.1. Safety Review Approach ................................................................................................ 62 8.2. Review of the Safety Database – GE-189-002 and GE-012-096 .................................... 63 8.2.1. Overall Exposure ..................................................................................................... 63 8.2.2. Deaths ..................................................................................................................... 63 8.2.3. Serious Adverse Events ........................................................................................... 64 8.2.4. Treatment Emergent Adverse Events and Adverse Reactions ............................... 65 8.2.5. Laboratory Findings ................................................................................................ 69 8.2.6. Vital Signs ................................................................................................................ 70 8.3. Analysis of Submission-Specific Safety Issues ................................................................ 71 8.3.1. Drug-drug interaction with beta blockers .............................................................. 71 8.4. Safety in the Postmarket Setting.................................................................................... 72 8.4.1. Safety Concerns Identified Through Postmarket Experience ................................. 72 8.5. Integrated Assessment of Safety ................................................................................... 75 9 Advisory Committee Meeting and Other External Consultations ......................................... 80 CDER Clinical Review Template 2015 Edition 3 Reference ID: 4068412 Clinical Review Karen Bleich NDA 020351 Supplement 44 (CCTA) Visipaque (iodixanol) 10 Labeling Recommendations .................................................................................................. 80 10.1. Prescribing Information .............................................................................................. 80 11 Risk Evaluation and Mitigation Strategies (REMS) ................................................................ 84 12 Postmarketing Requirements and Commitments ................................................................. 84 13 Appendices ............................................................................................................................ 84 13.1. References .................................................................................................................. 84 13.2. Financial Disclosure ...................................................................................................
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