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207500Orig1s000 / 207501Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207500Orig1s000 / 207501Orig1s000 MEDICAL REVIEW(S) Clinical Review Edward Weinstein, MD, PhD NDA 207500 and 207501, 505 (b)(1) Cresemba® (Isavuconazonium Sulfate) CLINICAL REVIEW Application Type NDA 505 (b)(1) Application Number(s) 207500 and 207501 Priority or Standard Priority Submit Date(s) July 8, 2014 Received Date(s) July 8, 2014 PDUFA Goal Date March 8, 2015 Division / Office Division of Anti-Infective Products / Office of Antimicrobial Products Reviewer Name(s) Edward Weinstein, MD, PhD Elizabeth O’Shaughnessy, MD Review Completion Date December 8, 2014 Established Name Isavuconazonium sulfate (BAL8557) (Proposed) Trade Name Cresemba ® Therapeutic Class Azole-class antifungal Applicant Astellas Pharma Global Development, Inc. Formulation(s) 1. Lyophilized powder for intravenous infusion 2. Hard capsules for oral administration Dosing Regimen 200 mg every 8 hours for the first 48 hours via oral or intravenous administration, then 200 mg per day via oral or intravenous administration. Indication(s) Treatment of 1) Invasive aspergillosis and 2) Invasive mucormycosis Intended Population(s) Adults, 18 years of age and older. 1 Reference ID: 3672337 Clinical Review Edward Weinstein, MD, PhD NDA 207500 and 207501, 505 (b)(1) Cresemba® (Isavuconazonium Sulfate) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ....................................... 10 1.1 Recommendation on Regulatory Action ........................................................... 10 1.2 Risk Benefit Assessment .................................................................................. 10 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies . 14 1.4 Recommendations for Postmarket Requirements and Commitments .............. 14 2 INTRODUCTION AND REGULATORY BACKGROUND ...................................... 15 2.1 Product Information .......................................................................................... 15 2.2 Tables of Currently Available Treatments for Proposed Indications ................. 15 2.3 Availability of Proposed Active Ingredient in the United States ........................ 16 2.4 Important Safety Issues with Consideration to Related Drugs .......................... 16 2.5 Summary of Presubmission Regulatory Activity Related to Submission .......... 17 2.6 Other Relevant Background Information .......................................................... 19 3 ETHICS AND GOOD CLINICAL PRACTICES ....................................................... 19 3.1 Submission Quality and Integrity ...................................................................... 19 3.2 Compliance with Good Clinical Practices ......................................................... 20 3.3 Financial Disclosures ........................................................................................ 25 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES ......................................................................................................... 25 4.1 Chemistry Manufacturing and Controls ............................................................ 25 4.2 Clinical Microbiology ......................................................................................... 25 4.3 Preclinical Pharmacology/Toxicology ............................................................... 25 4.4 Clinical Pharmacology ...................................................................................... 25 4.4.1 Mechanism of Action .................................................................................. 26 4.4.2 Pharmacodynamics.................................................................................... 26 4.4.3 Pharmacokinetics ....................................................................................... 26 5 SOURCES OF CLINICAL DATA............................................................................ 27 5.1 Tables of Studies/Clinical Trials ....................................................................... 27 5.2 Review Strategy ............................................................................................... 41 5.3 Discussion of Individual Studies/Clinical Trials ................................................. 41 6 REVIEW OF EFFICACY ......................................................................................... 46 Efficacy Summary: ..................................................................................................... 46 6.1 Indication: Treatment of Invasive Aspergillosis ................................................. 47 6.1.1 Methods ..................................................................................................... 47 2 Reference ID: 3672337 Clinical Review Edward Weinstein, MD, PhD NDA 207500 and 207501, 505 (b)(1) Cresemba® (Isavuconazonium Sulfate) 6.1.2 Demographics ............................................................................................ 51 6.1.3 Subject Disposition .................................................................................... 55 6.1.4 Analysis of Primary Endpoint(s) ................................................................. 59 6.1.5 Analysis of Secondary Endpoints(s)........................................................... 60 6.1.6 Other Endpoints ......................................................................................... 65 6.1.7 Subpopulations .......................................................................................... 65 6.1.8 Analysis of Clinical Information Relevant to Dosing Recommendations .... 68 6.1.9 Discussion of Persistence of Efficacy and/or Tolerance Effects ................. 68 6.1.10 Additional Efficacy Issues/Analyses ........................................................... 69 6.2 Indication: Treatment of Invasive Mucormycosis .............................................. 70 6.2.1 Methods ..................................................................................................... 70 6.2.2 Demographics ............................................................................................ 73 6.2.3 Subject Disposition .................................................................................... 79 6.2.4 Analysis of Primary Endpoint(s) ................................................................. 82 6.2.5 Analysis of Secondary Endpoints(s)........................................................... 85 6.2.6 Other Endpoints ......................................................................................... 86 6.2.7 Subpopulations .......................................................................................... 86 6.2.8 Analysis of Clinical Information Relevant to Dosing Recommendations .... 87 6.2.9 Discussion of Persistence of Efficacy and/or Tolerance Effects ................. 88 6.2.10 Additional Efficacy Issues/Analyses ........................................................... 90 7 REVIEW OF SAFETY ............................................................................................. 98 Safety Summary ........................................................................................................ 98 7.1 Methods ............................................................................................................ 99 7.1.1 Studies/Clinical Trials Used to Evaluate Safety ......................................... 99 7.1.2 Categorization of Adverse Events ............................................................ 101 7.1.3 Pooling of Data Across Studies/Clinical Trials to Estimate and Compare Incidence .................................................................................................. 102 7.2 Adequacy of Safety Assessments .................................................................. 102 7.2.1 Overall Exposure at Appropriate Doses/Durations and Demographics of Target Populations ................................................................................... 102 7.2.2 Explorations for Dose Response .............................................................. 104 7.2.3 Special Animal and/or In Vitro Testing ..................................................... 105 7.2.4 Routine Clinical Testing ........................................................................... 105 7.2.5 Metabolic, Clearance, and Interaction Workup ........................................ 106 7.2.6 Evaluation for Potential Adverse Events for Similar Drugs in Drug Class 106 7.3 Major Safety Results ...................................................................................... 107 7.3.1 Deaths ...................................................................................................... 107 7.3.2 Nonfatal Serious Adverse Events ............................................................ 123 7.3.3 Dropouts and/or Discontinuations ............................................................ 130 7.3.4 Significant Adverse Events ...................................................................... 134 7.3.5 Submission Specific Primary Safety Concerns ........................................ 150 7.4 Supportive Safety Results .............................................................................. 157 7.4.1 Common Adverse Events ........................................................................ 157 3 Reference ID: 3672337 Clinical Review Edward Weinstein, MD, PhD NDA 207500 and 207501, 505 (b)(1) Cresemba® (Isavuconazonium Sulfate) 7.4.2 Laboratory
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