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761172Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 761172Orig1s000 INTEGRATED REVIEW BLA 761172 Ansuvimab-zykl Integrated Review Table 1. Administrative Application Information Category Application Information Application type BLA Application number(s) 761172 Priority or standard Priority Submit date(s) 5/29/2020 Received date(s) 5/29/2020 PDUFA goal date 1/29/2021 Division/office Division of Antivirals (DAV) Review completion date 12/21/2020 Established/proper name Ansuvimab-zykl (Proposed) proprietary name Ebanga Pharmacologic class Zaire ebolavirus glycoprotein-directed monoclonal antibody Code name Ansuvimab-zykl (mAb114; VRCEBOMAB092-00-AB) Applicant Ridgeback Biotherapeutics, LP Dosage form(s)/formulation(s) Solution for injection Dosing regimen The recommended dosage of Ebanga is 50 mg/kg diluted and administered as a single intravenous infusion administered over 60 minutes Applicant proposed Treatment of infection caused by Zaire ebolavirus indication(s)/ population(s) Proposed SNOMED indication 37109004 | Ebola virus disease (disorder) Regulatory action Approval Approved dosage (if For injection: 400 mg of ansuvimab-zykl, available as an off- applicable) white to white lyophilized powder in single-dose vial for reconstitution and further dilution. Approved indication(s)/ EBANGA is indicated for the treatment of infection caused by population(s) (if applicable) Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. Limitations of Use The efficacy of EBANGA has not been established for other species of the Ebolavirus and Marburgvirus genera. Zaire ebolavirus can change over time, and factors such as emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding whether to use EBANGA Approved SNOMED term for 37109004 | Ebola virus disease (disorder) indication (if applicable) i Integrated Review Template, version 2.0 (04/23/2020) Reference ID: 4720109 BLA 761172 Ansuvimab-zykl Table of Contents Table of Tables .................................................................................................................. vi Table of Figures ...................................................................................................................x Glossary ............................................................................................................................1 I. Executive Summary ..........................................................................................................3 1. Summary of Regulatory Action ...................................................................................3 2. Benefit-Risk Assessment ..............................................................................................6 2.1. Benefit-Risk Framework .......................................................................................6 2.2. Conclusions Regarding Benefit-Risk ..................................................................10 II. Interdisciplinary Assessment .........................................................................................11 3. Introduction ................................................................................................................11 3.1. Review Issue List .................................................................................................11 3.1.1. Key Review Issues Relevant to Evaluation of Benefit .................................11 3.1.2. Key Review Issues Relevant to Evaluation of Risk ......................................12 3.2. Approach to the Review ......................................................................................12 4. Patient Experience Data .............................................................................................16 5. Pharmacologic Activity, Pharmacokinetics, and Clinical Pharmacology ..................17 5.1. Nonclinical Assessment of Potential Effectiveness .............................................19 6. Assessment of Effectiveness ......................................................................................23 6.1. Dose and Dose Responsiveness ...........................................................................23 6.2. Clinical Trials Intended to Demonstrate Efficacy ...............................................23 6.2.1. Trial Design ...................................................................................................23 6.2.2. Eligibility Criteria .........................................................................................24 6.2.3. Statistical Analysis Plan ................................................................................25 6.2.4. Results of Analyses of Clinical Trials/Studies Intended to Demonstrate Benefit to Patients ................................................................25 6.3. Review Issues Relevant to the Evaluation of Benefit ..........................................32 6.3.1. Use of an Investigational Drug, ZMapp, as an Active Control Versus Optimized Standard of Care Alone ...........................................................32 6.3.2. Lower Efficacy in Subjects With a Baseline CtNP of 22 or Lower..............34 6.3.3. Adequacy of Clinical Experience With Pediatric Subjects and Inclusion of Labeling for Neonates Born to EBOV-Infected Mothers ......................................................................................................36 6.3.4. Lack of Clinical Experience With Ansuvimab-zykl for Treatment of EBOV Infection Acquired by Routes Other Than Natural Transmission .............................................................................................37 6.3.5. Use of an Inadequately Validated Bioanalytical Assay for Quantitation of Ansuvimab-zykl Concentrations in Serum of Healthy Humans ........................................................................................39 ii Integrated Review Template, version 2.0 (04/23/2020) Reference ID: 4720109 BLA 761172 Ansuvimab-zykl 7. Risk and Risk Management ........................................................................................40 7.1. Potential Risks or Safety Concerns Based on Nonclinical Data ..........................40 7.2. Potential Risks or Safety Concerns Based on Drug Class or Other Drug- Specific Factors ................................................................................................41 7.3. Potential Safety Concerns Identified Through Postmarket Experience ..............41 7.4. FDA Approach to the Safety Review ..................................................................41 7.5. Adequacy of Clinical Safety Database ................................................................43 7.6. Safety Findings and Concerns Based on Review of Clinical Safety Database ...........................................................................................................45 7.6.1. Overall Adverse Event Summary .................................................................45 7.6.2. Deaths ............................................................................................................48 7.6.3. Serious Adverse Events.................................................................................49 7.6.4. Dropouts and/or Discontinuations Due to Adverse Events ..........................52 7.6.5. Treatment-Emergent Adverse Events ...........................................................52 7.6.6. Laboratory Findings ......................................................................................56 7.6.7. Vital Signs .....................................................................................................57 7.7. Key Review Issues Relevant to Evaluation of Risk ............................................57 7.7.1. Risks Associated With Endotoxin Levels for the Proposed Total Infusion Volumes for Pediatrics, and Administration Issues in Neonates ....................................................................................................58 7.7.2. Development of Resistance Against Ansuvimab-zykl Has Not Been Adequately Characterized .........................................................................61 7.7.3. Potential Risks of Immunogenicity ...............................................................62 8. Therapeutic Individualization ....................................................................................63 8.1. Intrinsic Factors ...................................................................................................63 8.2. Drug Interactions .................................................................................................63 8.3. Plans for Pediatric Drug Development ................................................................63 8.4. Pregnancy and Lactation ......................................................................................64 9. Product Quality ..........................................................................................................66 9.1. Device or Combination Product Considerations .................................................68 10. Human Subjects Protections/Clinical Site and Other Good Clinical Practice Inspections/Financial Disclosure ............................................................................68 11. Advisory Committee Summary ................................................................................69
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