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210132Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210132Orig1s000 CLINICAL REVIEW(S) -Clinical Review Theresa H. van der Vlugt, M.D., M.P.H. Standard NDA 210132 Bijuva™ (estradiol and progesterone) capsules, for oral use CLINICAL REVIEW Application Type 505(b)(2) Application Number(s) NDA 210132 Priority or Standard Standard Submit Date(s) December 28, 2017 Received Date(s) December 28, 2017 PDUFA Goal Date October 28, 2018 Division/Office Division of Bone, Reproductive, and Urologic Products/ Office of Drug Evaluation III Reviewer Name(s) Theresa H. van der Vlugt, M.D., M.P.H. Review Completion Date October 25, 2017 Established/Proper Name Estradiol and progesterone capsules, for oral use (Proposed) Trade Name Bijuva™ Applicant TherapeuticsMD Dosage Form(s) Oral softgel capsule Applicant Proposed Dosing Combined 1 mg estradiol and 100 mg progesterone Regimen(s) administered orally daily (b) (4) Applicant Proposed Treatment of moderate to severe vasomotor symptoms in a Indication(s)/Population(s) woman with an intact uterus Recommendation on Approval of the combined 1 mg estradiol and 100 mg Regulatory Action progesterone dosage strength is recommended. (b) (4) Recommended Postmenopausal women with a uterus Indication(s)/Population(s) (if applicable) CDER Clinical Review Template 1 Version date: September 6, 2017 for all NDAs and BLAs Reference ID: 43408264343508 -Clinical Review Theresa H. van der Vlugt, M.D., M.P.H. Standard NDA 210132 Bijuva™ (estradiol and progesterone) capsules, for oral use Table of Contents Glossary ..........................................................................................................................................9 1. Executive Summary...............................................................................................................11 1.1. Product Introduction ...............................................................................................11 1.2. Conclusions on the Substantial Evidence of Effectiveness ......................................11 1.3. Benefit-Risk Assessment..........................................................................................11 1.4. Patient Experience Data ..........................................................................................15 2. Therapeutic Context..............................................................................................................15 2.1. Analysis of Condition ...............................................................................................15 2.2. Analysis of Current Treatment Options ...................................................................16 3. Regulatory Background .........................................................................................................17 3.1. U.S. Regulatory Actions and Marketing History.......................................................17 3.2. Summary of Presubmission/Submission Regulatory Activity ..................................18 3.3. Foreign Regulatory Actions and Marketing History.................................................32 4. Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety ................................................................................................................32 4.1. Office of Scientific Investigations (OSI)....................................................................32 4.2. Product Quality........................................................................................................34 4.3. Clinical Microbiology................................................................................................39 4.4. Nonclinical Pharmacology/Toxicology.....................................................................40 4.5. Clinical Pharmacology..............................................................................................41 4.6. Devices and Companion Diagnostic Issues ..............................................................54 4.7. Consumer Study Reviews.........................................................................................54 5. Sources of Clinical Data and Review Strategy .......................................................................54 5.1. Table of Clinical Studies ...........................................................................................54 5.2. Review Strategy .......................................................................................................56 6. Review of Relevant Individual Trials Used to Support Efficacy .............................................56 6.1. Trial TXC12-05..........................................................................................................56 6.1.1. Study Design ...........................................................................................................56 CDER Clinical Review Template 2 Version date: September 6, 2017 for all NDAs and BLAs Reference ID: 43408264343508 -Clinical Review Theresa H. van der Vlugt, M.D., M.P.H. Standard NDA 210132 Bijuva™ (estradiol and progesterone) capsules, for oral use 6.1.2. Study Results ..........................................................................................................76 7. Integrated Review of Effectiveness.....................................................................................108 7.1. Assessment of Efficacy Across Trials......................................................................108 7.1.1. Primary Endpoints ................................................................................................108 7.1.2. Secondary and Other Endpoints...........................................................................108 7.1.3. Subpopulations.....................................................................................................108 7.1.4. Dose and Dose-Response .....................................................................................109 7.1.5. Onset, Duration, and Durability of Efficacy Effects...............................................109 7.2. Additional Efficacy Considerations ........................................................................109 7.2.1. Considerations on Benefit in the Postmarket Setting...........................................109 7.2.2. Other Relevant Benefits........................................................................................109 7.3. Integrated Assessment of Effectiveness................................................................109 8. Review of Safety..................................................................................................................109 8.1. Safety Review Approach........................................................................................109 8.2. Review of the Safety Database ..............................................................................111 8.2.1. Overall Exposure...................................................................................................112 8.2.2. Relevant characteristics of the safety population: ...............................................113 8.2.3. Adequacy of the safety database: ........................................................................113 8.3. Adequacy of Applicant’s Clinical Safety Assessments............................................114 8.3.1. Issues Regarding Data Integrity and Submission Quality......................................114 8.3.2. Categorization of Adverse Events.........................................................................114 8.3.3. Routine Clinical Tests............................................................................................115 8.4. Safety Results.........................................................................................................117 8.4.1. Deaths...................................................................................................................117 8.4.2. Serious Adverse Events.........................................................................................118 8.4.3. Dropouts and/or Discontinuations Due to Adverse Effects..................................120 8.4.4. Significant Adverse Events....................................................................................124 8.4.5. Treatment Emergent Adverse Events and Adverse Reactions .............................136 8.4.6. Laboratory Findings ..............................................................................................138 8.4.7. Vital Signs..............................................................................................................141 CDER Clinical Review Template 3 Version date: September 6, 2017 for all NDAs and BLAs Reference ID: 43408264343508 -Clinical Review Theresa H. van der Vlugt, M.D., M.P.H. Standard NDA 210132 Bijuva™ (estradiol and progesterone) capsules, for oral use 8.4.8. Electrocardiograms (ECGs) ...................................................................................141 8.4.9. QT .........................................................................................................................143 8.4.10. Immunogenicity.............................................................................................143 8.5. Analysis of Submission-Specific Safety Issues........................................................143 8.5.1. Endometrium........................................................................................................143 8.6. Safety Analyses
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