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CLINICAL REVIEW(S) Clinical Review Kenneth Bergmann, MD NDA 210875 – Resubmission (CR) Kynmobi (APL-130277, Apomorphine)

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CLINICAL REVIEW(S) Clinical Review Kenneth Bergmann, MD NDA 210875 – Resubmission (CR) Kynmobi (APL-130277, Apomorphine) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210875Orig1s000 CLINICAL REVIEW(S) Clinical Review Kenneth Bergmann, MD NDA 210875 – Resubmission (CR) Kynmobi (APL-130277, apomorphine) CLINICAL REVIEW Application Type Resubmission – Class 2 (Complete Response) 505(b)(2) Type 3 New Dosage Form Application Number(s) NDA 210875 Priority or Standard Standard Submit Date(s) 2019 November 21 Received Date(s) 2019 November 21 PDUFA Goal Date 2020 May 21 Division/Office DN I, ON, OND Reviewer Name(s) Kenneth Bergmann, MD Review Completion Date 2020 May 20 Established/Proper Name APL-130277 (apomorphine hydrochloride sublingual thin film) (Proposed) Trade Name KYNMOBI Applicant Sunovion Dosage Form(s) Sublingual thin film (b) (4) Applicant Proposed Dosing 10, 15, 20, 25, 30 mg sublingually up to five times daily Regimen(s) separated by at least 2 hours Applicant Proposed For the acute, intermittent treatment of “off” episodes Indication(s)/Population(s) associated with Parkinson’s disease Recommendation on Approvable, up to 30 mg per dose. Regulatory Action Recommended Adults with Parkinson’s disease and “off” episodes Indication(s)/Population(s) CDER Clinical Review Template 1 Version date: September 6, 2017 for all NDAs and BLAs Reference ID: 46121114613103 Clinical Review Kenneth Bergmann, MD NDA 210875 – Resubmission (CR) Kynmobi (APL-130277, apomorphine) Table of Contents Glossary ........................................................................................................................................... 8 1. Executive Summary ............................................................................................................... 10 Recommendation on Regulatory Action ........................................................................ 10 Introduction to the Complete Response ........................................................................ 10 Summary of the Previous Conclusion on Effectiveness ................................................. 11 Summary of the Evaluation of Clinical Safety ................................................................ 12 Risk – Benefit Assessment .............................................................................................. 13 2. Therapeutic Context .............................................................................................................. 13 3. Regulatory Background ......................................................................................................... 14 U.S. Regulatory Actions and Marketing History ............................................................. 14 Summary of Presubmission/Submission Regulatory Activity ........................................ 14 Foreign Regulatory Actions and Marketing History ....................................................... 15 4. Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety................................................................................................................. 16 Human Factors ............................................................................................................... 16 Clinical Pharmacology .................................................................................................... 17 5. Sources of Clinical Data and Review Strategy ....................................................................... 17 Relevant Clinical Studies ................................................................................................ 17 Review Strategy .............................................................................................................. 19 6. Review of Relevant Individual Trials Used to Support Efficacy ............................................. 20 7. Integrated Review of Effectiveness ....................................................................................... 20 8. Review of Safety .................................................................................................................... 20 Safety Review Approach ................................................................................................ 20 Review of the Safety Database ...................................................................................... 20 Overall Exposure ..................................................................................................... 20 Relevant characteristics of the safety population: ................................................. 26 Adequacy of the safety database: .......................................................................... 27 CDER Clinical Review Template 2 Version date: September 6, 2017 for all NDAs and BLAs Reference ID: 46121114613103 Clinical Review Kenneth Bergmann, MD NDA 210875 – Resubmission (CR) Kynmobi (APL-130277, apomorphine) Adequacy of Applicant’s Clinical Safety Assessments .................................................... 27 Issues Regarding Data Integrity and Submission Quality ....................................... 27 Categorization of Adverse Events ........................................................................... 27 Routine Clinical Tests .............................................................................................. 28 Safety Results ................................................................................................................. 28 Deaths ..................................................................................................................... 28 Serious Adverse Events ........................................................................................... 29 Dropouts and/or Discontinuations Due to Adverse Effects ................................... 31 Significant Adverse Events ...................................................................................... 34 Treatment Emergent Adverse Events and Adverse Reactions ............................... 36 Laboratory Findings ................................................................................................ 38 Vital Signs ................................................................................................................ 38 Electrocardiograms (ECGs) ...................................................................................... 39 Analysis of Submission-Specific Safety Issues ................................................................ 39 Oral Mucosal Irritation ............................................................................................ 39 Systemic Hypersensitivity ....................................................................................... 44 Integrated Assessment of Safety ................................................................................... 57 9. Advisory Committee Meeting and Other External Consultations ......................................... 58 10. Labeling Recommendations .................................................................................................. 58 Prescription Drug Labeling ......................................................................................... 58 11. Risk Evaluation and Mitigation Strategies (REMS) ................................................................ 59 12. Postmarketing Requirements and Commitments ................................................................. 59 13. Appendices ............................................................................................................................ 59 References .................................................................................................................. 59 Financial Disclosure .................................................................................................... 59 Preferred Terms by Adverse Event Cluster. ............................................................... 60 Oropharyngeal edema ..................................................................................... 60 Oropharyngeal inflammation / erythema ....................................................... 60 Oropharyngeal discoloration ........................................................................... 60 Oropharyngeal infections ................................................................................ 60 CDER Clinical Review Template 3 Version date: September 6, 2017 for all NDAs and BLAs Reference ID: 46121114613103 Clinical Review Kenneth Bergmann, MD NDA 210875 – Resubmission (CR) Kynmobi (APL-130277, apomorphine) Oropharyngeal mass / neoplasm..................................................................... 61 Oropharyngeal numbness / changes in sensation .......................................... 63 Oropharyngeal pain ......................................................................................... 63 Oropharyngeal ulcerations .............................................................................. 63 Alterations in taste .......................................................................................... 63 Salivary complaints and oral dryness .............................................................. 64 Dental complaints ............................................................................................ 64 Trauma ............................................................................................................. 64 Other ................................................................................................................ 65 Systemic hypersensitivity ...............................................................................
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