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761105Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 761105Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA/BLA Multi-disciplinary Review and Evaluation – BLA 761105 (Skyrizi, Risankizumab) NDA/BLA Multi-disciplinary Review and Evaluation Application Type BLA Application Number(s) 761105 Priority or Standard Standard Submit Date(s) 4/23/2018 Received Date(s) 4/23/2018 PDUFA Goal Date 4/23/2019 Division/Office ODE 3/DDDP Review Completion Date April 17, 2019 Established Name Risankizumab (Proposed) Trade Name Skyrizi Pharmacologic Class An interleukin-23 antagonist Code name Applicant AbbVie, Inc. Formulation(s) Solution for injection Dosing Regimen 150 mg administered by subcutaneous injection at Weeks 0, 4, and every twelve weeks thereafter Applicant Proposed For the treatment of moderate to severe plaque psoriasis in Indication(s)/Population(s) adults Recommendation on Approval Regulatory Action Recommended For the treatment of adults with moderate-to-severe plaque Indication(s)/Population(s) psoriasis who are candidates for systemic therapy or (if applicable) phototherapy. 1 Version date: February 1, 2016 for initial rollout (NME/original BLA reviews) Reference ID: 4422774 NDA/BLA Multi-disciplinary Review and Evaluation – BLA 761105 (Skyrizi, Risankizumab) Table of Contents Reviewers Team and Signature Approval Section ..................................................................... 7 Additional Reviewers of Application ..........................................................................................10 Glossary....................................................................................................................................12 1 Executive Summary ...........................................................................................................14 1.1. Product Introduction....................................................................................................14 1.2. Conclusions on the Substantial Evidence of Effectiveness..........................................14 1.3. Benefit-Risk Assessment ............................................................................................15 2 Therapeutic Context...........................................................................................................25 2.1. Analysis of Condition ..................................................................................................25 2.2. Analysis of Current Treatment Options .......................................................................25 3 Regulatory Background......................................................................................................32 3.1. U.S. Regulatory Actions and Marketing History...........................................................32 3.2. Summary of Presubmission/Submission Regulatory Activity.......................................32 4 Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety............................................................................................................34 4.1. Office of Scientific Investigations (OSI) .......................................................................34 4.2. Product Quality ...........................................................................................................35 4.3. Clinical Microbiology ...................................................................................................46 4.4. Devices and Companion Diagnostic Issues ................................................................46 5 Nonclinical Pharmacology/Toxicology................................................................................46 5.1. Executive Summary....................................................................................................46 5.2. Referenced NDAs, BLAs, DMFs .................................................................................48 5.3. Pharmacology.............................................................................................................48 5.4. ADME/PK ...................................................................................................................50 5.5. Toxicology ..................................................................................................................52 5.5.1. General Toxicology..............................................................................................52 5.5.2. Genetic Toxicology ..............................................................................................53 5.5.3. Carcinogenicity ....................................................................................................53 5.5.4. Reproductive and Developmental Toxicology ......................................................54 5.5.5. Other Toxicology Studies.....................................................................................55 6 Clinical Pharmacology........................................................................................................57 6.1. Executive Summary....................................................................................................57 2 Version date: February 1, 2016 for initial rollout (NME/original BLA reviews) Reference ID: 4422774 NDA/BLA Multi-disciplinary Review and Evaluation – BLA 761105 (Skyrizi, Risankizumab) 6.2. Summary of Clinical Pharmacology Assessment ........................................................58 6.2.1. Pharmacology and Clinical Pharmacokinetics......................................................58 6.2.2. General Dosing and Therapeutic Individualization ...............................................59 6.3. Comprehensive Clinical Pharmacology Review ..........................................................60 6.3.1. General Pharmacology and Pharmacokinetic Characteristics ..............................60 6.3.2. Clinical Pharmacology Questions.........................................................................62 7 Statistical and Clinical Evaluation.......................................................................................67 7.1. Sources of Clinical Data and Review Strategy ............................................................67 7.1.1. Table of Clinical Studies ......................................................................................67 7.1.2. Review Strategy...................................................................................................73 7.2. Review of Relevant Individual Trials Used to Support Efficacy....................................73 7.2.1. Study Design and Endpoints.................................. Error! Bookmark not defined. 7.2.2. Statistical Methodologies ....................................... Error! Bookmark not defined. 7.2.3. Subject Disposition, Demographics, and Baseline Disease Characteristics ...Error! Bookmark not defined. 7.2.4. Results for the Primary Efficacy Endpoint .............. Error! Bookmark not defined. 7.2.5. Results for the Secondary Efficacy Endpoints........ Error! Bookmark not defined. 7.2.6. Patient Reported Outcomes (PROs) ...................... Error! Bookmark not defined. 7.2.7. Findings in Special/Subgroup Populations ............. Error! Bookmark not defined. 7.2.7.1. Sex, Race, Age, and Geographic Region........ Error! Bookmark not defined. 7.2.7.2. Other Special/Subgroup Populations .............. Error! Bookmark not defined. 7.3. Review of Safety.......................................................................................................103 7.3.1. Safety Review Approach....................................................................................103 7.3.2. Review of the Safety Database..........................................................................106 7.3.3. Adequacy of Applicant’s Clinical Safety Assessments .......................................107 7.3.4. Safety Results....................................................................................................108 7.3.5. Analysis of Submission-Specific Safety Issues ..................................................116 7.3.6. Safety Analyses by Demographic Subgroups ....................................................135 7.3.7. Specific Safety Studies/Clinical Trials ................................................................135 7.3.8. Additional Safety Explorations ...........................................................................137 7.3.9. Safety in the Postmarket Setting........................................................................140 7.3.10. Integrated Assessment of Safety ................................................................141 7.4. Summary and Conclusions .......................................................................................143 7.4.1. Statistical Issues................................................................................................143 7.4.2. Conclusions and Recommendations..................................................................143 8 Advisory Committee Meeting and Other External Consultations ......................................145 3 Version date: February 1, 2016 for initial rollout (NME/original BLA reviews) Reference ID: 4422774 NDA/BLA Multi-disciplinary Review and Evaluation – BLA 761105 (Skyrizi, Risankizumab) 9 Pediatrics.........................................................................................................................146
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