`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
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`214900Orig1s000
`
`MULTI-DISCIPLINE REVIEW
`Summary Review
`Office Director
`Cross Discipline Team Leader Review
`Clinical Review
`Non-Clinical Review
`Statistical Review
`Clinical Pharmacology Review
`
`

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`NDA Multi-disciplinary Review and Evaluation - NDA 214900
`BREXAFEMME (ibrexafungerp)
`
`
`Treatment
`candidiasis
`72605008 Candidal vulvovaginitis (disorder)
`
` adult women with vulvovaginal
`
`Approval
`
`Treatment of adult and post-menarchal pediatric females with
`vulvovaginal candidiasis (VVC)
`72605008 Candidal vulvovaginitis (disorder)
`
`NDA Multi-Disciplinary Review and Evaluation
`Application Type NDA
`Application Number 214900
`Priority or Standard Priority
`Submit Date October 01, 2020
`Received Date October 01, 2020
`PDUFA Goal Date
`June 01, 2021
`Division/Office Division of Anti-Infectives/Office of Infectious Diseases
`Review Completion Date
`June 1, 2021
`Established/Proper Name
`Ibrexafungerp
`(Proposed) Trade Name BREXAFEMME
`Pharmacologic Class Triterpenoid antifungal
`Code names SCY-078, MK-3118
`Applicant SCYNEXIS, Inc.
`Dosage form Tablet
`Applicant proposed Dosing
`300 mg (two tablets of 150 mg) twice a day for one day
`Regimen
`Applicant Proposed
`Indication/Population
`Applicant Proposed
`SNOMED CT Indication
`Disease Term for each
`Proposed Indication
`Recommendation on
`Regulatory Action
`Recommended
`Indication/Population
`Recommended SNOMED
`CT Indication Disease
`Term for each Indication
`Recommended Dosing
`Regimen
`
`300 mg (two tablets of 150 mg) administered approximately 12
`hours apart for one day;
`with concomitant use of a strong CYP3A inhibitor, adjust dose
`to 150 mg (one of the 150 mg tablet) administered
`approximately 12 hours apart for one day
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`Version date: October 12, 2018
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`Reference ID: 4804396
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`(b) (4)
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`NDA Multi-disciplinary Review and Evaluation - NDA 214900
`BREXAFEMME (ibrexafungerp)
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`Table of Contents
`Table of Tables .............................................................................................................................. 5
`Table of Figures ............................................................................................................................. 9
`Reviewers of Multi-Disciplinary Review and Evaluation .............................................................. 10
`Glossary ...................................................................................................................................... 15
`1
`Executive Summary .............................................................................................................. 17
` Product Introduction .................................................................................................... 17
` Conclusions on the Substantial Evidence of Effectiveness ............................................ 17
` Benefit-Risk Assessment ............................................................................................... 18
` Patient Experience Data ............................................................................................... 22
`Therapeutic Context ............................................................................................................ 23
` Analysis of Condition .................................................................................................... 23
` Analysis of Current Treatment Options ........................................................................ 24
`Regulatory Background ........................................................................................................ 27
` U.S. Regulatory Actions and Marketing History ............................................................ 27
`Summary of Presubmission/Submission Regulatory Activity ........................................ 27
`
`Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on
`Efficacy and Safety ............................................................................................................... 31
` Office of Scientific Investigations (OSI) ......................................................................... 31
` Product Quality ............................................................................................................. 31
`Clinical Microbiology ....................................................................................................34
` Devices and Companion Diagnostic Issues ................................................................... 40
`5 Nonclinical Pharmacology/Toxicology ................................................................................. 41
` Executive Summary ...................................................................................................... 41
` Referenced NDAs, BLAs, DMFs ..................................................................................... 43
` Pharmacology ............................................................................................................... 43
` ADME/PK ...................................................................................................................... 45
` Toxicology ..................................................................................................................... 54
` General Toxicology ................................................................................................ 54
` Genetic Toxicology ................................................................................................ 65
` Carcinogenicity ...................................................................................................... 67
` Reproductive and Developmental Toxicology ....................................................... 67
` Other Toxicology Studies ....................................................................................... 77
`Clinical Pharmacology .......................................................................................................... 78
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` Executive Summary ...................................................................................................... 78
`Summary of Clinical Pharmacology Assessment ........................................................... 79
`
` Pharmacology and Clinical Pharmacokinetics ........................................................ 79
` General Dosing and Therapeutic Individualization ................................................ 79
` Comprehensive Clinical Pharmacology Review ............................................................. 80
` General Pharmacology and Pharmacokinetic Characteristics ................................ 80
` Clinical Pharmacology Questions ........................................................................... 82
`Sources of Clinical Data and Review Strategy ...................................................................... 89
` Table of Clinical Studies ................................................................................................ 89
` Review Strategy ............................................................................................................ 93
`Statistical and Clinical Evaluation ......................................................................................... 94
` Review of Relevant Individual Trials Used to Support Efficacy ..................................... 94
` Study SCY-078-303 ................................................................................................ 94
` Study SCY-078-306 .............................................................................................. 105
` Assessment of Efficacy Across Trials .................................................................... 116
` Integrated Assessment of Effectiveness .............................................................. 117
` Review of Safety ......................................................................................................... 118
` Safety Review Approach ...................................................................................... 118
` Review of the Safety Database ............................................................................ 119
` Adequacy of Applicant’s Clinical Safety Assessments .......................................... 126
` Safety Results ...................................................................................................... 129
` Analysis of Submission-Specific Safety Issues ...................................................... 146
` Clinical Outcome Assessment (COA) Analyses Informing Safety/Tolerability ...... 152
` Safety Analyses by Demographic Subgroups ....................................................... 152
` Specific Safety Studies/Clinical Trials ................................................................... 153
` Additional Safety Explorations ............................................................................. 153
`Safety in the Postmarket Setting .................................................................. 156
`
`Integrated Assessment of Safety .................................................................. 157
`
`Statistical Issues .......................................................................................................... 158
`
` Conclusions and Recommendations ........................................................................... 158
`9 Advisory Committee Meeting and Other External Consultations ...................................... 160
`10 Pediatrics ........................................................................................................................... 161
`11 Labeling Recommendations ............................................................................................... 165
`Prescription Drug Labeling ......................................................................................165
`12 Risk Evaluation and Mitigation Strategies (REMS) ............................................................. 169
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`NDA Multi-disciplinary Review and Evaluation - NDA 214900
`BREXAFEMME (ibrexafungerp)
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`13 Postmarketing Requirements and Commitment ............................................................... 170
`14 Division Director (Clinical) Comments ................................................................................ 170
`15 Office Director (or designated signatory authority) Comments ......................................... 171
`16 Appendices ........................................................................................................................ 172
`References .............................................................................................................. 172
`
`Financial Disclosure ................................................................................................. 172
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`Clinical Microbiology ............................................................................................... 174
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`OCP Appendices (Technical documents supporting OCP recommendations) ......... 176
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`Bioanalytical Methods .................................................................................. 176
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`Individual Study Reviews ............................................................................. 179
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`Pharmacometrics Review ............................................................................. 212
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`Clinical Safety Appendix .......................................................................................... 221
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`Reference ID: 4804396
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`NDA Multi-disciplinary Review and Evaluation - NDA 214900
`BREXAFEMME (ibrexafungerp)
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`Table of Tables
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`Table 2-1 Summary of Treatments for Vulvovaginal Candidiasis .............................................. 25
`Table 4-1: The Amounts of Each Excipient in a 150 mg Ibrexafungerp Tablet and the Daily Dose
`of Ibrexafungerp. ........................................................................................................................ 31
`Table 4-2: Qualification of all the Specified Impurities in the Ibrexafungerp Drug Substance. ... 32
`Table 4-3. Baseline fungal organisms by treatment groups in SCY-078-303 and SCY-078-306
`(mITT population) ....................................................................................................................... 37
`Table 4-4. Clinical Cure and Mycological eradication response at TOC by baseline ibrexafungerp
`MIC - mITT population (SCY-078-303) ......................................................................................... 38
`Table 4-5. Clinical Cure and Mycological eradication response at TOC by baseline ibrexafungerp
`MIC - mITT population (SCY-078-306) ......................................................................................... 38
`Table 5-1: Intravenous PK Results for SCY-O78 Administered in a Single Dose to Rats (Adapted
`from Table in the Study Report) .................................................................................................. 46
`Table 5-2: Oral PK Results for SCY-O78 Administered in a Single Dose to Rats (Adapted from
`Table in the Study Report) .......................................................................................................... 46
`Table 5-3: In Vitro Metabolism of [3H]MK-3118 in Liver Microsomes of Human and Preclinical
`Species. (Table from the Study Report) ....................................................................................... 48
`Table 5-4: In Vitro Metabolism of [3H]MK-3118 in Liver Microsomes of Human and Preclinical
`Species. (Table from the Study Report) ....................................................................................... 48
`Table 5-5: Percent [3H]SCY-078 Excreted as Parent Compound or Metabolites in Bile, Urine, and
`Feces of Male Rats. (Table from the Study Report) ..................................................................... 49
`Table 5-6: Metabolites Following Incubation of SCY-078 Citrate with Rat, Dog, and Human Liver
`and Intestinal Microsomes. (Adapted from Table in the Study Report) ...................................... 50
`Table 5-7: Metabolites Detected in Dog Plasma Following Single Oral (40 mg/kg) and IV (15
`mg/kg) Doses of SCY-078 Citrate Salt. (Table from the Study Report) ........................................ 51
`Table 5-8: Organ Weights in the 1-month Study in Rats. ............................................................ 56
`Table 5-9: Stomach Histopathology Findings at the End of Dosing in the 13-Week Toxicology
`Study in Rats. (Table from the study report) ............................................................................... 62
`Table 6-1. Summary of OCP Recommendations & Comments on Key Review Issues ................. 78
`Table 6-2. Pharmacokinetic Properties of Ibrexafungerp ............................................................ 79
`Table 6-3. General Pharmacology and Pharmacokinetic Characteristics..................................... 80
`Table 6-4. Summary of Statistical Analyses for Ibrexafungerp Food Effect Comparison for the
`Citrate Salt Tablet ....................................................................................................................... 83
`Table 6-5. Study SCY-078-102: Most Common Adverse Events by Treatment Group ................. 84
`Table 6-6. Clinical Cure and Mycological Eradication at the TOC Visit: SCY-078-303, SCY- 078-
`306, SCY-078-204 – mITT ............................................................................................................ 84
`Table 6-7. TEAEs at 5% Frequency or Greater in SCY-078-303 and SCY-078-306 Compared to
`Study SCY-078-204 - Safety Population ....................................................................................... 85
`Table 6-8. Summary of Statistical Analysis for Ibrexafungerp by Treatment Per-Protocol
`Population ................................................................................................................................... 85
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`NDA Multi-disciplinary Review and Evaluation - NDA 214900
`BREXAFEMME (ibrexafungerp)
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`Table 6-9. Summary of Statistical Analysis for Ibrexafungerp by Treatment – Per-Protocol
`Population ................................................................................................................................... 86
`Table 6-10. Summary of Pharmacokinetic Parameters of Ibrexafungerp Tablet and
`Ibrexafungerp Tablet Co-administered with Pantoprazole ......................................................... 87
`Table 6-11. Effect of Ibrexafungerp on Pharmacokinetics of Coadministered Drugs .................. 88
`Table 7-1. Listing of Clinical Trials Relevant to this NDA.............................................................. 90
`Table 8-1: Analysis Populations for Study 303 ............................................................................ 98
`Table 8-2: Subject Disposition in Study 303 (ITT Population) ..................................................... 98
`Table 8-3: Major Protocol Deviations in Study 303 (ITT Population) ........................................... 99
`Table 8-4: Demographic Characteristics in Study 303 (mITT population) .................................. 100
`Table 8-5: Use of Rescue Medications in Study 303 (mITT Population) .................................... 101
`Table 8-6: Clinical Cure at TOC Visit in Study 303 (mITT population) ........................................ 102
`Table 8-7: Clinical Cure at TOC for Various Subgroups in Study 303 (mITT population) ............ 102
`Table 8-8: Mycological Eradication at TOC Study 303 (mITT population) .................................. 103
`Table 8-9: Overall Success at TOC Study 303 (mITT population) ............................................... 104
`Table 8-10: Clinical Improvement at TOC Study 303 (mITT population) .................................... 104
`Table 8-11: Clinical Cure at FU Study 303 (mITT population) .................................................... 104
`Table 8-12: Analysis Populations for Study 306 ........................................................................ 108
`Table 8-13: Subject Disposition in Study 306 (ITT Population) .................................................. 109
`Table 8-14: Major Protocol Deviations in Study 306 (ITT Population) ....................................... 109
`Table 8-15: Demographic Characteristics in Study 306 (mITT population) ................................ 110
`Table 8-16: Use of Rescue Medications in Study 306 (mITT Population) .................................. 112
`Table 8-17: Clinical Cure at TOC Visit in Study 306 (mITT population) ...................................... 112
`Table 8-18: Clinical Cure at TOC for Various Subgroups in Study 306 (mITT population) .......... 113
`Table 8-19: Mycological Eradication at TOC Study 306 (mITT population) ................................ 113
`Table 8-20: Overall Success at TOC Study 306 (mITT population) ............................................. 114
`Table 8-21: Clinical Improvement at TOC Study 306 (mITT population) .................................... 115
`Table 8-22: Clinical Cure at FU Study 306 (mITT population) .................................................... 115
`Table 8-23: Clinical Cure at TOC Study 303 and 306 (mITT population) .................................... 116
`Table 8-24: Secondary Efficacy Endpoints Study 303 and 306 (mITT population) ..................... 117
`Table 8-25 Oral Ibrexafungerp Safety Population, Size and Denominators ............................... 120
`Table 8-26 Demographic Characteristics – Pooled Phase 3 Safety Population .......................... 124
`Table 8-27 Other Baseline Characteristics – Pooled Phase 3 Safety Population ........................ 124
`Table 8-28 Adverse Event Recoded Preferred Terms – Pooled Phase 3 Trials .......................... 126
`Table 8-29 Serious Adverse Events – Pooled Phase 3 Trials ...................................................... 129
`Table 8-30 Study Discontinuations – Pooled Phase 3 Trials ...................................................... 131
`Table 8-31 Overview of Treatment-Emergent Adverse Events – Pooled Phase 3 Trials ............ 133
`Table 8-32 TEAE Occurring in >2% Subjects – Pooled Phase 3 Trials ......................................... 135
`Table 8-33 Adverse Reactions Occurring in < 2% of Subjects -- Pooled Phase 3 Trials .............. 136
`Table 8-34 TEAE Incidence by Country – Pooled Phase 3 .......................................................... 137
`Table 8-35 Gastrointestinal TEAEs in the Fed and Fasted State – Phase 1 Trial SCY-078-102 ... 139
`Table 8-36 Ibrexafungerp-treated Subjects with Transaminase Elevations > 3x ULN – All Trials
` .................................................................................................................................................. 141
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`NDA Multi-disciplinary Review and Evaluation - NDA 214900
`BREXAFEMME (ibrexafungerp)
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`Table 8-37 Subjects With Post-Treatment D-dimer Elevations – SCY-078-111 .......................... 142
`Table 8-38. Change in QTcF by Ibrexafungerp Dose .................................................................. 144
`Table 8-39 TEAE Incidence by Demographic Subgroup – Pooled Phase 3 Trials ..................... 152
`Table 8-40 Pregnancies Reported After Ibrexafungerp Exposure -- All Trials ............................ 155
`Table 10-1 Studies Evaluating Incidence of Candida sp. in Samples From Pediatric Patients .... 161
`Table 11-1 Proposed Revisions to Common Adverse Reactions Table in Ibrexafungerp PI ....... 165
`Table 11-2: Proposed Table for Section 14 of Ibrexafungerp PI ............................................... 168
`Table 16-1. Activity of ibrexafungerp against Candida isolates (Surveillance Studies) .............. 174
`Table 16-2. Activity of ibrexafungerp against echinocandin resistant Candida isolates ............ 175
`Table 16-3. Validation Reports of Quantification of Ibrexafungerp in Plasma .......................... 176
`Table 16-4. Validation Reports of Quantification of Ibrexafungerp in Urine ............................. 178
`Table 16-5. Summary of Ibrexafungerp Pharmacokinetic Parameters Following Single Oral Doses
`of Ibrexafungerp (10 mg to 1600 mg) ....................................................................................... 180
`Table 16-6. Summary of Plasma Ibrexafungerp Pharmacokinetic Results ................................. 181
`Table 16-7. Summary of Plasma and Urine Ibrexafungerp Pharmacokinetics Following the
`Administration of Multiple Oral Doses of 750 mg Ibrexafungerp BID (Days 1 and 2) and 750 mg
`Ibrexafungerp QD (Days 3 - 7) – Day 1 and Day 7 (PK Population) ............................................ 182
`Table 16-8. Summary of Plasma Ibrexafungerp Pharmacokinetic Results ................................. 184
`Table 16-9. Summary of Between-Population Comparisons (Elderly Subgroups in Protocol 003
`and Healthy Young Males in Protocol 001) for Ibrexafungerp AUC0-(cid:1100)(cid:853) (cid:18)(cid:373)(cid:258)(cid:454)(cid:853) (cid:258)(cid:374)(cid:282) (cid:4)(cid:104)(cid:18)(cid:1004)-24hr –
`Per Protocol Population ............................................................................................................ 185
`Table 16-10. Mean Cumulative Amount Excreted of Total Radioactivity in Urine, Feces and Urine
`and Feces Combined Following a Single Oral Dose of [14C]-Ibrexafungerp to Healthy Male
`Subjects ..................................................................................................................................... 186
`Table 16-11. Ibrexafungerp Exposure in Plasma, Vaginal Secretions, and Vaginal Tissue ......... 187
`Table 16-12. Intrinsic Clearance and Oxidative Metabolite Formation of Ibrexafungerp in Human
`Liver Microsomes ...................................................................................................................... 189
`Table 16-13. Intrinsic Clearance and Oxidative Metabolite Formation of Ibrexafungerp in
`Recombinant Human P450s ...................................................................................................... 189
`Table 16-14. UGT Reaction Phenotyping ................................................................................... 190
`Table 16-15. Effect of Ibrexafungerp on Cytochrome P450 Activity in Pooled Human Liver
`Microsomes (Reversible Inhibition) .......................................................................................... 192
`Table 16-16. Estimated IC50 Values for Reversible Inhibition of CYP Enzymes by SCY-078 in
`Human Liver Microsomes ......................................................................................................... 193
`Table 16-17. Ki Values and Mode of Inhibition of CYP Enzymes by SCY-078 in Human Liver
`Microsomes .............................................................................................................................. 194
`Table 16-18. Summary of Inhibition of Human Liver UGTs by Ibrexafungerp ........................... 198
`Table 16-19. Evaluation of Potential Ibrexafungerp Inhibition of Uptake Transporters ............ 200
`Table 16-20. Summary of Statistical Analysis for Ibrexafungerp PK Parameters by Treatment
`Group ........................................................................................................................................ 201
`Table 16-21. Summary of Statistical Analysis for SCY-078 by Treatment Per-Protocol Population
` .................................................................................................................................................. 201
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`NDA Multi-disciplinary Review and Evaluation - NDA 214900
`BREXAFEMME (ibrexafungerp)
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`Table 16-22. Summary of Pharmacokinetic Parameters of Ibrexafungerp Tablet and
`Ibrexafungerp Tablet Co-administered with Pantoprazole ....................................................... 203
`Table 16-23. Summary of Statistical Analysis for Tacrolimus Co-administered with Ibrexafungerp
`Compared to Tacrolimus Administered Alone .......................................................................... 204
`Table 16-24. Summary of Statistical Analysis for Rosiglitazone Co-administered with
`Ibrexafungerp Compared to Rosiglitazone Administered Alone On Rosiglitazone .................... 205
`Table 16-25. Statistical Analysis of Effect of Multiple Doses of Ibrexafungerp on the Single Dose
`PK Parameters of Dabigatran .................................................................................................... 207
`Table 16-26. Statistical Analysis of Effect of Multiple Doses of Ibrexafungerp on the Single Dose
`PK Parameters of Pravastatin .................................................................................................... 207
`Table 16-27. High-Fat and Low-Fat Breakfast Content and Composition .................................. 209
`Table 16-28. Summary of Statistical Analyses for Ibrexafungerp- Panel A Food Effect
`Comparison for the Citrate Salt Tablet following Standard High Fat Meal ................................ 209
`Table 16-29. Summary of Statistical Analyses for Ibrexafungerp Food Effect Comparison for
`Panel A Citrate Salt Treatment A, 600 mg (4 x 150-mg) Fasted Versus Panel B Citrate Salt
`Treatment F following Standard Low-Fat Meal ......................................................................... 210
`Table 16-30. Summary of Statistical Analysis for Ibrexafungerp 250 mg x2 Tablets Administered
`Fasting by Formulation ............................................................................................................. 211
`Table 16-31. Specific Comments on Applicant’s Final Population PK model ............................. 212
`Table 16-32. Summary of Clinical Study Designs ....................................................................... 214
`Table 16-33. Population Pharmacokinetic Parameter Estimates for the Final Model ............... 217
`Table 16-34. Summary of exposures (Cmax, AUC0-24) from simulation of VVC patients receiving
`150 mg BID, 300 mg BID, and 600 mg BID of ibrexafungerp ..................................................... 221
`Table 16-35 Serious Adverse Events – Pooled Phase 1 Trials .................................................... 221
`Table 16-36 Study Discontinuations Due to Adverse Events – Phase 2 Trial SCY-078-204 ........ 221
`Table 16-37 Study Discontinuations Due to Adverse Events – Pooled Phase 1 Trials ................ 222
`Table 16-38 Overview of Treatment-Emergent Adverse Events – Phase 2 Trials ...................... 224
`Table 16-39 Overview of Treatment-Emergent Adverse Events – Pooled Phase 1 ................... 225
`Table 16-40 TEAE by Severity and Duration – Pooled Phase 3 Trials ......................................... 225
`Table 16-41 Gastrointestinal TEAE by Severity and Duration – Pooled Phase 3 Trials .............. 225
`Table 16-42 TEAE Occurring in >2% Subjects – SCY-078-203 Proof-of-Concept Trial ................ 226
`Table 16-43 TEAE Occurring in >2% Subjects – SCY-078-204 Dose-Finding Trial ....................... 227
`Table 16-44 TEAE Occurring in >2% Subjects – Pooled Phase 1 Trials ....................................... 227
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`Reference ID: 4804396
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`NDA Multi-disciplinary Review and Evaluation - NDA 214900
`BREXAFEMME (ibrexafungerp)
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`Table of Figures
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`Figure 1: Proposed Metabolic Products of [14C]SCY-078 in Han Wistar Rats. (Figure from the
`Study Report) .............................................................................................................................. 52
`Figure 2: Proposed Metabolic Products of [14C]SCY-078 in the Plasma, Urine, and Feces of
`Beagle Dogs. (Figure from the Study Report) .............................................................................. 52
`Figure 3. Proposed Biotransformation Products of Ibrexafungerp in Humans .......................... 191
`Figure 4. CYP1A2 fold change: The effect of treating cultured human hepatocytes with
`ibrexafungerp on CYP1A2 mRNA levels ..................................................................................... 195
`Figure 5. CYP2B6 fold change: The effect of treating cultured human hepatocytes with
`ibrexafungerp on CYP2B6 mRNA levels ..................................................................................... 195
`Figure 6. CYP3A4 fold change: The effect of treating cultured human hepatocytes with
`ibrexafungerp on CYP3A4 mRNA levels ..................................................................................... 196
`Figure 7. Schematic of the PK model for ibrexafungerp ............................................................ 215
`Figure 8. Goodness-of-fit plots for final covariate model .......................................................... 218
`Figure 9. pcVPC plots for final covariate model ........................................................................ 219
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`Version date: October 12, 2018
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`Reference ID: 4804396
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`NDA Multi-disciplinary Review and Evaluation - NDA 214900
`BREXAFEMME (ibrexafungerp)
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`Reviewers of Multi-Disciplinary Review and Evaluation
`
`Regulatory Project Manager
`Chief, Regulatory Project Management Staff
`Nonclinical Reviewer
`Nonclinical Team Leader
`Office of Clinical Pharmacology Reviewer(s)
`Office of Clinical Pharmacology Team Leader(s)
`Clinical Reviewer
`Clinical Team Leader
`Statistical Reviewer
`Acting Associate Division Director (OB/DBIV)
`Clinical Microbiology Reviewer
`Clinical Microbiology Team Leader
`Cross-Disciplinary Team Leader
`Division Director (DPT-ID)
`Division Director (OCP)
`Division Director (DAI)
`Office Deputy Director (OID)
`
`Jacquelyn Rosenberger, PharmD, RAC
`Maureen Dillon-Parker, MS, RAC
`James S. Wild, PhD
`Terry Miller, PhD
`Cristina Miglis, PharmD, MS, BCPS
`Zhixia (Grace) Yan Danielsen, PhD
`Heidi Smith, MD, PhD
`Thomas Smith, MD
`Cheryl Dixon, PhD
`Karen Higgins, ScD
`Simone Shurland, PhD
`Avery Goodwin, PhD
`Thomas Smith, MD
`Hanan Ghantous, PhD, DABT
`Kellie Reynolds