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Prucalopride for the Treatment of Chronic Idiopathic Constipation FDA Advisory Committee Meeting Briefing Document Gastrointesti

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Prucalopride for the Treatment of Chronic Idiopathic Constipation FDA Advisory Committee Meeting Briefing Document Gastrointesti Prucalopride for the Treatment of Chronic Idiopathic Constipation FDA Advisory Committee Meeting Briefing Document Gastrointestinal Drugs Advisory Committee Meeting Date: 18 October 2018 Shire Page 2 Gastrointestinal Drugs Advisory Committee Briefing Document Prucalopride for Chronic Idiopathic Constipation 18 Oct 2018 Meeting TABLE OF CONTENTS 1. EXECUTIVE SUMMARY ....................................................................................................15 1.1 Unmet Need..............................................................................................................16 1.2 Mechanism of Action...............................................................................................17 1.3 Clinical Pharmacology .............................................................................................17 1.4 Efficacy ....................................................................................................................18 1.4.1 Efficacy Results .....................................................................................................21 1.4.2 Efficacy Conclusions .............................................................................................33 1.5 Safety........................................................................................................................35 1.5.1 Safety in Randomized Double-blind Placebo-controlled Studies..........................37 1.5.2 Cardiovascular Safety Assessment ........................................................................44 1.5.2.1 In Vitro and In Vivo Nonclinical Cardiovascular Testing .....................45 1.5.2.2 Studies with Intense Cardiovascular Monitoring (Thorough QT and Phase 1 Cardiovascular Monitoring)......................................................46 1.5.2.3 Events from Randomized Double-Blind Placebo-Controlled Studies and Open-Label Extensions with QT Prolongation, Arrhythmia, and Ischemia .................................................................................................46 1.5.2.4 Independent Blinded Adjudication for MACE of the Randomized Double-Blind Placebo-Controlled Studies.............................................47 1.5.2.5 Pharmacoepidemiology Study 802 (EUPAS9200) ................................49 1.6 Conclusions ..............................................................................................................50 2. BACKGROUND ON CHRONIC IDIOPATHIC CONSTIPATION ....................................51 2.1 Overview of Chronic Idiopathic Constipation .........................................................51 2.1.1 Clinical Diagnosis..................................................................................................52 2.1.2 Types of Bowel Movements ..................................................................................53 2.1.3 Goal of Treatment..................................................................................................53 2.2 Treatment for Chronic Idiopathic Constipation .......................................................53 2.2.1 Non-prescription Treatment...................................................................................53 2.2.2 Prosecretory Agents...............................................................................................53 2.2.3 Prokinetic Agents...................................................................................................54 2.3 Patient Medical Need ...............................................................................................54 3. PRODUCT DESCRIPTION...................................................................................................55 3.1 Proposed Indication..................................................................................................55 3.2 Dosing Regimen.......................................................................................................55 3.3 Mechanism of Action...............................................................................................55 3.3.1 Selective vs. Non-selective 5-HT4 Agonists..........................................................55 4. REGULATORY AND DEVELOPMENT HISTORY...........................................................61 4.1 Regulatory Milestones..............................................................................................61 ADVISORY COMMITTEE BRIEFING MATERIALS: AVAILABLE FOR PUBLIC RELEASE Shire Page 3 Gastrointestinal Drugs Advisory Committee Briefing Document Prucalopride for Chronic Idiopathic Constipation 18 Oct 2018 Meeting 4.2 Clinical Development Program................................................................................61 4.3 Global Regulatory Approvals...................................................................................62 5. CLINICAL PHARMACOLOGY...........................................................................................63 5.1 Pharmacokinetics .....................................................................................................63 5.1.1 Pharmacokinetics in Renal Impairment.................................................................64 5.1.2 Population Pharmacokinetics.................................................................................64 5.2 Drug-Drug Interactions ............................................................................................65 5.3 Pharmacodynamics...................................................................................................65 5.4 Dose Selection..........................................................................................................67 6. CLINICAL EFFICACY .........................................................................................................68 6.1 Clinical Study Design...............................................................................................68 6.1.1 Inclusion and Exclusion Criteria............................................................................70 6.1.2 Endpoints ...............................................................................................................70 6.1.3 Statistical Analyses ................................................................................................71 6.2 Demographic and Baseline Characteristics..............................................................72 6.3 Patient Disposition ...................................................................................................77 6.4 Primary Endpoint Results: Proportion of Patients with an Average of ≥3 CSBMs/week Over 12 Weeks of Treatment ............................................................79 6.4.1 Alternative Endpoint A: Proportion of Patients with an Average of ≥3 CSBMs/week and ≥1 CSBM/week for ≥9/12 Weeks including 3/4 of the Last Weeks of Treatment.......................................................................................82 6.4.2 Study 401 Investigation .........................................................................................85 6.5 Secondary Endpoint Results.....................................................................................85 6.5.1 Proportion of Patients with an Average Increase of ≥1 CSBM/Week...................85 6.5.2 Time to First CSBM and SBM ..............................................................................87 6.5.3 Average Number of CSBMs..................................................................................89 6.5.4 Use of Rescue Medication (Bisacodyl)..................................................................92 6.5.5 Patient Assessment of Constipation – Symptoms (PAC-SYM) ............................95 6.5.6 Patient Assessment of Constipation – Quality of Life (PAC-QOL)....................101 6.6 Subgroup Analyses.................................................................................................107 6.6.1 Subgroup Analysis by Age ..................................................................................107 6.6.2 Subgroup Analysis by Sex...................................................................................108 6.6.3 Subgroup Analysis by Race.................................................................................109 6.6.4 Subgroup Analysis by Region .............................................................................110 6.7 Efficacy Conclusions..............................................................................................113 7. CLINICAL SAFETY............................................................................................................116 7.1 Treatment Exposure ...............................................................................................117 7.2 Safety Pooling Strategy..........................................................................................119 ADVISORY COMMITTEE BRIEFING MATERIALS: AVAILABLE FOR PUBLIC RELEASE Shire Page 4 Gastrointestinal Drugs Advisory Committee Briefing Document Prucalopride for Chronic Idiopathic Constipation 18 Oct 2018 Meeting 7.3 Overview of Adverse Events in Pooled Randomized Double-blind Placebo- controlled Studies ≥4 Weeks..................................................................................119 7.3.1 Common Adverse Events (≥2%) .........................................................................120 7.3.2 Onset and Duration of Adverse Events................................................................122 7.4 Serious Adverse Events in Pooled Randomized Double-blind Placebo-
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