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209885Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209885Orig1s000 CLINICAL REVIEW(S) Clinical Review Anand Mattai M.D. sNDA 209885 Austedo (Deutetrabenazine) CLINICAL REVIEW Application Type sNDA 505(b)(2) Application Number(s) 209885 Priority or Standard Priority Submit Date(s) 2017 February 28 Received Date(s) 2017 February 28 PDUFA Goal Date 2017 August 30 Division/Office Division of Psychiatric Products, ODE 1. OND, CDER Reviewer Name(s) Anand Mattai M.D. Review Completion Date 2017 July 29 Established Name Deutetrabenazine (SD-809) (Proposed) Trade Name Austedo Applicant Teva Pharmaceuticals, Inc. Formulation(s) Oral tablets: 6 mg, 9 mg, and 12 mg Dosing Regimen Titrated by clinical response up to 24 mg BID Applicant Proposed Treatment of Tardive Dyskinesia Indication(s)/Population(s) Recommendation on Approval Regulatory Action Recommended Indication(s)/Population(s) (if applicable) CDER Clinical Review Template 2015 Edition 1 Version date: November 5, 2015 for initial rollout (NME/original BLA reviews) Reference ID: 4135055 Clinical Review Anand Mattai M.D. sNDA 209885 Austedo (Deutetrabenazine) 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 ................................................................................................11 2 Therapeutic Context..............................................................................................................17 2.1. Analysis of Condition......................................................................................................17 2.2. Analysis of Current Treatment Options .........................................................................18 3 Regulatory Background .........................................................................................................20 3.1. U.S. Regulatory Actions and Marketing History.............................................................20 3.2. Summary of Presubmission/Submission Regulatory Activity ........................................21 3.3. Foreign Regulatory Actions and Marketing History .......................................................23 4 Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety ................................................................................................................23 4.1. Office of Scientific Investigations (OSI) ..........................................................................23 4.2. Product Quality ..............................................................................................................25 4.3. Clinical Microbiology......................................................................................................25 4.4. Nonclinical Pharmacology/Toxicology ...........................................................................25 4.5. Clinical Pharmacology ....................................................................................................25 4.5.1. Mechanism of Action..............................................................................................25 4.5.2. Pharmacodynamics.................................................................................................25 4.5.3. Pharmacokinetics....................................................................................................25 5 Sources of Clinical Data and Review Strategy .......................................................................25 5.1. Table of Clinical Studies .................................................................................................26 5.2. Review Strategy .............................................................................................................30 6 Review of Relevant Individual Trials Used to Support Efficacy .............................................30 6.1. Study C-18: Randomized (1:1) double-blind placebo-controlled flexible dose study of SD-809 for the treatment of TD................................................................................................30 CDER Clinical Review Template 2015 Edition 2 Version date: November 5, 2015 for initial rollout (NME/original BLA reviews) Reference ID: 4135055 Clinical Review Anand Mattai M.D. sNDA 209885 Austedo (Deutetrabenazine) 6.1.1. Study Design ...........................................................................................................30 6.1.2. Study Results ..........................................................................................................45 6.2. C-23: Randomized, double-blind, placebo-controlled, fixed-dose study of SD-809 for the treatment of tardive dyskinesia .........................................................................................57 6.2.1. Study Design ...........................................................................................................57 6.2.2. Study Results ..........................................................................................................66 6.3. SD-809-C-20: An Open-Label, Long-Term Safety Study of SD-809 for the Treatment of Moderate to Severe Tardive Dyskinesia...................................................................................80 6.3.1. Study Results ..........................................................................................................87 7 Integrated Review of Effectiveness.......................................................................................97 7.1. Assessment of Efficacy Across Trials..............................................................................97 7.1.1. Primary Endpoints ..................................................................................................97 7.1.2. Secondary and Other Endpoints.............................................................................98 7.1.3. Subpopulations.......................................................................................................98 7.1.4. Dose and Dose-Response .......................................................................................99 7.1.5. Onset, Duration, and Durability of Efficacy Effects.................................................99 7.2. Integrated Assessment of Effectiveness ......................................................................100 8 Review of Safety..................................................................................................................102 8.1. Safety Review Approach ..............................................................................................102 8.2. Review of the Safety Database ....................................................................................103 8.2.1. Overall Exposure...................................................................................................103 8.2.2. Relevant characteristics of the safety population: ...............................................105 8.3. Adequacy of Applicant’s Clinical Safety Assessments..................................................106 8.3.1. Issues Regarding Data Integrity and Submission Quality......................................106 8.3.2. Categorization of Adverse Events.........................................................................106 8.4. Safety Results...............................................................................................................107 8.4.1. Deaths...................................................................................................................107 8.4.2. Serious Adverse Events.........................................................................................112 8.4.3. Dropouts and/or Discontinuations Due to Adverse Effects..................................115 8.4.4. Scope of Adverse Events.......................................................................................116 8.4.5. Treatment Emergent Adverse Events and Adverse Reactions .............................117 CDER Clinical Review Template 2015 Edition 3 Version date: November 5, 2015 for initial rollout (NME/original BLA reviews) Reference ID: 4135055 Clinical Review Anand Mattai M.D. sNDA 209885 Austedo (Deutetrabenazine) 8.4.6. Laboratory Findings ..............................................................................................120 8.4.7. Vital Signs..............................................................................................................122 8.4.8. Electrocardiograms (ECGs) ...................................................................................123 8.4.9. QT .........................................................................................................................125 8.5. Analysis of Submission-Specific Safety Issues..............................................................128 8.5.1. Depression and Suicidality....................................................................................128 8.5.2. Sedation and Somnolence ....................................................................................133 8.5.3. Parkinsonism.........................................................................................................134
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