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Amikacin Liposome Inhalation Suspension Antimicrobial Drugs Advisory Committee Briefing Document 07 August 2018 Meeting

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Amikacin Liposome Inhalation Suspension Antimicrobial Drugs Advisory Committee Briefing Document 07 August 2018 Meeting Amikacin Liposome Inhalation Suspension Antimicrobial Drugs Advisory Committee Briefing Document 07 August 2018 Meeting AMIKACIN LIPOSOME INHALATION SUSPENSION ADVISORY COMMITTEE BRIEFING MATERIALS: AVAILABLE FOR PUBLIC RELEASE ANTIMICROBIAL DRUGS ADVISORY COMMITTEE MEETING DATE: 07 AUGUST 2018 1 Amikacin Liposome Inhalation Suspension Antimicrobial Drugs Advisory Committee Briefing Document 07 August 2018 Meeting TABLE OF CONTENTS TABLE OF CONTENTS .................................................................................................................2 List of Tables ...................................................................................................................................7 List of Figures ................................................................................................................................10 LIST OF ABBREVIATIONS ........................................................................................................11 1 EXECUTIVE SUMMARY ........................................................................................13 1.1 Background and Unmet Need .....................................................................................14 1.2 Regulatory ...................................................................................................................17 1.2.1 Indication Statement ...................................................................................................17 1.2.2 Regulatory History ......................................................................................................17 1.3 Efficacy .......................................................................................................................18 1.3.1 Study 212 ....................................................................................................................18 1.3.2 Study 312 ....................................................................................................................25 1.3.3 Study 112 ....................................................................................................................29 1.3.4 Efficacy Summary ......................................................................................................32 1.4 Safety ..........................................................................................................................33 1.4.1 Adverse Events of Special Interest .............................................................................37 1.5 Conclusions.................................................................................................................38 2 BACKGROUND ON NONTUBERCULULOUS MYCOBACTERIAL LUNG INFECTIONS .................................................................................................40 2.1 Overview of Nontuberculous Mycobacterial Lung Infections ...................................40 2.1.1 Epidemiology ..............................................................................................................40 2.1.2 Morbidity and Mortality in Nontuberculous Mycobacterial Lung Infections ............41 2.2 Current Treatment Options .........................................................................................42 2.3 Patient Medical Need ..................................................................................................44 3 PRODUCT DESCRIPTION .......................................................................................45 3.1 ALIS Description ........................................................................................................45 3.2 Lamira Nebulizer System ...........................................................................................45 3.3 Mechanism of Action .................................................................................................46 3.4 In Vitro and In Vivo Studies .......................................................................................47 3.4.1 Biodistribution ............................................................................................................47 3.4.2 Intracellular Accumulation of Amikacin in Macrophages .........................................47 2 Amikacin Liposome Inhalation Suspension Antimicrobial Drugs Advisory Committee Briefing Document 07 August 2018 Meeting 3.4.3 Effect of Residual Amikacin in Sputum Samples ......................................................48 4 REGULATORY AND DEVELOPMENT HISTORY ...............................................49 4.1 Regulatory History ......................................................................................................49 4.2 Clinical Development Program ..................................................................................50 5 CLINICAL PHARMACOLOGY ...............................................................................53 5.1 Dose Rationale ............................................................................................................53 5.2 Pharmacokinetics ........................................................................................................55 5.3 Population Pharmacokinetics ......................................................................................57 6 CLINICAL EFFICACY .............................................................................................58 6.1 Efficacy Overview ......................................................................................................58 6.1.1 Endpoint Definitions ...................................................................................................58 6.1.1.1 Culture Conversion .....................................................................................................58 6.1.1.2 Semi-Quantitative Scale for Mycobacterial Culture ...................................................59 6.1.1.3 6 Minute Walk Test (6MWT) .....................................................................................60 6.1.1.4 St. George’s Respiratory Questionnaire (SGRQ) .......................................................60 6.2 Study 212 ....................................................................................................................60 6.2.1 Study Design ...............................................................................................................60 6.2.1.1 Inclusion and Exclusion Criteria ................................................................................61 6.2.1.2 Statistical Analyses .....................................................................................................62 6.2.2 Demographic and Baseline Characteristics ................................................................62 6.2.3 Patient Disposition ......................................................................................................65 6.2.4 Primary Endpoint – Proportion of Patients Achieving Culture Conversion by Month 6 .......................................................................................................................66 6.2.5 Secondary Endpoints ..................................................................................................67 6.2.5.1 Change from Baseline in 6 Minute Walk Test (6MWT) Distance at Month 6 ..........67 6.2.5.2 Time from Baseline to Culture Conversion ................................................................69 6.2.5.3 Change from Baseline in St. George’s Respiratory Questionnaire (SGRQ) at Month 6 .......................................................................................................................69 6.2.6 Exploratory Endpoints ................................................................................................70 6.2.6.1 Change from Baseline in 6 Minute Walk Test (6MWT) at Month 6 for Converters vs Non-converters for All Patients ...........................................................70 6.2.6.2 Change from Baseline in 6 Minute Walk Test (6MWT) at Month 6 for Converters vs Non- converters in the ALIS + Multidrug Regimen Arm ...................71 3 Amikacin Liposome Inhalation Suspension Antimicrobial Drugs Advisory Committee Briefing Document 07 August 2018 Meeting 6.2.6.3 Change from Baseline in 6 Minute Walk Test (6MWT) at Month 6 for Converters vs Non-converters in the Multidrug Regimen Alone Arm .......................72 6.2.7 Amikacin Resistance ..................................................................................................73 6.3 Study 312 ....................................................................................................................74 6.3.1 Overview .....................................................................................................................74 6.3.2 Demographic and Baseline Characteristics ................................................................75 6.3.3 Patient Disposition ......................................................................................................76 6.3.4 Secondary Endpoints ..................................................................................................77 6.3.4.1 Proportion of Patients Achieving Culture Conversion by Month 6 ...........................77 6.3.4.2 Time from Baseline to Culture Conversion ................................................................77 6.3.4.3 Change from Baseline in St. George’s Respiratory Questionnaire at Month 6 ..........78 6.4 Study 112 ....................................................................................................................78
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