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209627Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209627Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review Reviewers of Multi-Disciplinary Review and Evaluation SECTIONS OFFICE/ AUTHORED/ ACKNOWLEDGED/ DISCIPLINE REVIEWER DIVISION APPROVED Mark Seggel, Ph.D. OPQ/ONDP/DNDP2 Authored: Section 4.2 Digitally signed by Mark R. Seggel -S CMC Lead DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Mark R. Signature: Mark R. Seggel -S Seggel -S, 0.9.2342.19200300.100.1.1=1300071539 Date: 2018.08.08 16:29:15 -04'00' Frederic Moulin, DVM, PhD OND/ODE3/DBRUP Authored: Section 5 Pharmacology/ Digitally signed by Frederic Moulin -S Toxicology DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Reviewer Signature: Frederic Moulin -S 0.9.2342.19200300.100.1.1=2001708658, cn=Frederic Moulin -S Date: 2018.08.08 15:26:57 -04'00' Kimberly Hatfield, PhD OND/ODE3/DBRUP Approved: Section 5 Pharmacology/ Toxicology Digitally signed by Kimberly P. Hatfield -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Team Leader Signature: Kimberly P. Hatfield -S 0.9.2342.19200300.100.1.1=1300387215, cn=Kimberly P. Hatfield -S Date: 2018.08.08 14:56:10 -04'00' Li Li, Ph.D. OCP/DCP3 Authored: Sections 6 and 17.3 Clinical Pharmacology Dig ta ly signed by Li Li S DN c=US o=U S Government ou=HHS ou=FDA ou=People Reviewer cn=Li Li S Signature: Li Li -S 0 9 2342 19200300 100 1 1=20005 08577 Date 2018 08 08 15 39 23 04'00' Doanh Tran, Ph.D. OCP/DCP3 Approved: Sections 6 and 17.3 Clinical Pharmacology Digitally signed by Doanh C. Tran -S Team Leader Signature: Doanh C. Tran -S Date: 2018.08.08 14:49:57 -04'00' Physiologically Based Nan Zheng, Ph.D. OTS/OCP/DPM Authored: Sections 6 and 17.3 Pharmacokinetic D gitally s gned by Nan Zheng S DN: c US o U S Government ou HHS ou FDA ou People cn Nan Zheng S (PBPK) Reviewer Nan Zheng -S 0 9 2342 19200300 100 1 1 2000849162 Signature Date: 2018 08 09 11:36 42 04 00 Yuching Yang, Ph.D. OTS/OCP/DPM Approved Sections: 6 and 17.3 D gitally signed by Yuch ng Yang S PBPK Team Leader DN c=US o=U S Government ou=HHS ou=FDA ou=People cn=Yuch ng Yang S Yuching Yang -S 0 9 2342 19200300 100 1 1=2000846164 Signature: Date 2018 08 08 15 16 40 04'00' Gilbert J Burckart, Pharm.D. OCP/DCP3 Approved: Section 6 and 17.3 Clinical Pharmacology Associate Director Digitally signed by Gilbert J. Burckart -S Gilbert J. DN: c=US, o=U.S. Government, Office of Clinical Signature: ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=130038244 Pharmacology 7, cn=Gilbert J. Burckart -S Burckart -S Date: 2018.08.09 11:56:09 -04'00' Weiya Zhang, Ph.D. OB/DB3 Authored: Sections 8 and 9 Digitally signed by Weiya Zhang S Biostatistics DN: c US o U S Government ou HHS ou FDA ou People cn We ya Zhang S Signature: Weiya Zhang -S 0 9 2342 19200300 100 1 1 2001554924 Date: 2018 08 08 14:11:09 04 00 Biostatistics Mahboob Sobhan, PhD OB/DB3 Approved: Sections 8 and 9 Team Leader D gita ly signed by Mahboob Sobhan S DN: c=US o=U S Government ou=HHS ou=FDA ou=People Mahboob Sobhan -S cn=Mahboob Sobhan S 0 9 2342 19200300 100 1 1=1300084769 (Acting) Signature: Date: 2018 08 08 16:36:32 04'00' Reference ID: 4304958 Biostatistics Laura Lee Johnson, PhD OB/DB3 Approved: Sections 8 and 9 Division Director Digitally signed by Laura L. Johnson -S (Acting) DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Signature: Laura L. Johnson -S 0.9.2342.19200300.100.1.1=0011413414, cn=Laura L. Johnson -S Date: 2018.08.08 19:21:14 -04'00' Authored: Sections 1, 2, 3, 7, 8, 9, Abby Anderson, MD OND/DBRUP 10 Clinical Digitally signed by Abby Anderson -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, Signature: ou=People, cn=Abby Anderson -S, Abby Anderson -S 0.9.2342.19200300.100.1.1=2002091441 Date: 2018.08.08 14:08:57 -04'00' Authored: Sections 1, 4, 11, 12, Michelle Carey, MD, MPH OND/DBRUP 13, 14, 15, 16 CDTL Signature: see DARRTS signature page Audrey Gassman, M.D. OND/DBRUP Approved: All Sections DBRUP Signature: see DARRTS signature page Victor Crentsil, MD OND/ODE3 Approved: All Sections ODE 3 Signature: see DARRTS signature page Reference ID: 4304958 Multi-disciplinary Review and Evaluation NDA209627 ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) NDA/BLA Multi-disciplinary Review and Evaluation Application Type NDA Application Number(s) 209627 Priority or Standard Standard Submit Date(s) August 17, 2017 Received Date(s) August 17, 2017 PDUFA Goal Date August 17, 2018 Division/Office Division of Bone Reproductive and Urologic Products (DBRUP)/Office of Drug Evaluation III (ODE III) Review Completion Date August 8, 2018 Established Name Segesterone acetate and ethinyl estradiol vaginal system (Proposed) Trade Name Annovera Pharmacologic Class Combined hormonal contraceptive (CHC) (progestin + estrogen) Applicant Population Council Formulation(s) Segesterone acetate 150 μg/ethinyl estradiol 13 μg Dose Form Vaginal system (ring) Dosing Regimen Vaginal for 21 days per 28-day cycle Applicant Proposed Prevention of pregnancy in females of reproductive potential Indication(s)/Population(s) Recommendation on Approval Regulatory Action Recommended Same as above Indication(s)/Population(s) (if applicable) 1 Version date: February 1, 2016 for initial rollout (NME/original BLA reviews) Reference ID: 4304958 Multi-disciplinary Review and Evaluation NDA209627 ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) Table of Contents Reviewers of Multi-Disciplinary Review and Evaluation .............................................................. 10 Additional Reviewers of Application ............................................................................................. 10 1. Executive Summary ............................................................................................................... 12 1.1. Product Introduction ...................................................................................................... 12 1.2. Conclusions on the Substantial Evidence of Effectiveness ............................................ 13 1.3. Benefit-Risk Assessment ................................................................................................ 14 1.4. Patient Experience Data ................................................................................................. 19 2. Therapeutic Context .............................................................................................................. 20 2.1. Analysis of Condition ...................................................................................................... 20 2.2. Analysis of Current Treatment Options ......................................................................... 20 3. Regulatory Background ......................................................................................................... 22 3.1. U.S. Regulatory Actions and Marketing History ............................................................. 22 3.2. Summary of Presubmission/Submission Regulatory Activity ........................................ 22 3.3. Foreign Regulatory Actions and Marketing History ....................................................... 27 4. Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety................................................................................................................. 27 4.1. Office of Scientific Investigations (OSI) .......................................................................... 27 4.2. Product Quality .............................................................................................................. 28 4.3. Clinical Microbiology ...................................................................................................... 31 4.4. Devices and Companion Diagnostic Issues .................................................................... 31 5. Nonclinical Pharmacology/Toxicology................................................................................... 32 5.1. Executive Summary ........................................................................................................ 32 5.2. Referenced NDAs, BLAs, DMFs ....................................................................................... 37 5.3. Pharmacology ................................................................................................................. 37 5.3.1. Primary Pharmacology of Segesterone Acetate ..................................................... 37 5.3.2. Secondary Pharmacology of Segesterone Acetate ................................................. 38 5.3.3. Safety Pharmacology of Segesterone Acetate ........................................................ 40 5.3.4. Pharmacology of Ethinyl Estradiol .......................................................................... 41 5.4. ADME/PK ........................................................................................................................ 41 2 Version date: February 1, 2016 for initial rollout (NME/original BLA reviews) Reference ID: 4304958 Multi-disciplinary Review and Evaluation NDA209627 ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) 5.4.1. Pharmacokinetics of Segesterone Acetate ............................................................. 41 5.4.2. Pharmacokinetics of Ethinyl Estradiol .................................................................... 51 5.5. Toxicology
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