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Australian Public Assessment Report for Tafenoquine (As Succinate) Australian Public Assessment Report for Tafenoquine (as succinate) Proprietary Product Name: Kozenis Sponsor: GlaxoSmithKline Australia Pty Ltd November 2018 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) • The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating medicines and medical devices. • The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance) when necessary. • The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. • To report a problem with a medicine or medical device, please see the information on the TGA website <https://www.tga.gov.au>. About AusPARs • An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. • AusPARs are prepared and published by the TGA. • An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations and extensions of indications. • An AusPAR is a static document; it provides information that relates to a submission at a particular point in time. • A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA. Copyright © Commonwealth of Australia 2018 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <[email protected]>. AusPAR Kozenis tafenoquine (as succinate) GlaxoSmithKline Australia Pty Ltd PM-2017-04578-1-2 Page 2 of 77 Final 15 November 2018 Therapeutic Goods Administration Contents Common abbreviations _______________________________________________________ 5 I. Introduction to product submission _____________________________________ 8 Submission details ____________________________________________________________________ 8 Product background __________________________________________________________________ 8 Regulatory status ____________________________________________________________________ 10 Product Information_________________________________________________________________ 11 II. Registration time line ___________________________________________________ 11 III. Quality findings __________________________________________________________ 11 Drug substance (active ingredient) ________________________________________________ 11 Drug product _________________________________________________________________________ 12 Biopharmaceutics ___________________________________________________________________ 12 Quality summary and conclusions _________________________________________________ 13 IV. Nonclinical findings _____________________________________________________ 13 Introduction __________________________________________________________________________ 13 Pharmacology ________________________________________________________________________ 14 Pharmacokinetics ____________________________________________________________________ 17 Toxicology ____________________________________________________________________________ 18 Nonclinical summary ________________________________________________________________ 25 Nonclinical conclusions and recommendation ____________________________________ 27 V. Clinical findings ___________________________________________________________ 27 Introduction __________________________________________________________________________ 28 Pharmacokinetics ____________________________________________________________________ 29 Pharmacodynamics__________________________________________________________________ 31 Dosage selection for the pivotal studies ___________________________________________ 33 Efficacy _______________________________________________________________________________ 35 Safety _________________________________________________________________________________ 36 First round benefit-risk assessment _______________________________________________ 52 First round recommendation regarding authorisation ___________________________ 55 Second round evaluation ____________________________________________________________ 55 VI. Pharmacovigilance findings ___________________________________________ 55 Reconciliation of RMP evaluator recommendations ______________________________ 56 VII. Overall conclusion and risk/benefit assessment _________________ 57 Quality ________________________________________________________________________________ 57 Nonclinical ___________________________________________________________________________ 58 Clinical ________________________________________________________________________________ 58 AusPAR Kozenis tafenoquine (as succinate) GlaxoSmithKline Australia Pty Ltd PM-2017-04578-1-2 Page 3 of 77 Final 15 November 2018 Therapeutic Goods Administration Risk management plan ______________________________________________________________ 66 Risk-benefit analysis ________________________________________________________________ 66 Outcome ______________________________________________________________________________ 75 Attachment 1. Product Information ______________________________________ 75 Attachment 2. Extract from the Clinical Evaluation Report __________ 76 AusPAR Kozenis tafenoquine (as succinate) GlaxoSmithKline Australia Pty Ltd PM-2017-04578-1-2 Page 4 of 77 Final 15 November 2018 Therapeutic Goods Administration Common abbreviations Abbreviation Meaning ³ At or greater than £ At or lesser than < Less than > Greater than 90% CI Ninety per cent confidence interval ACT Artemisinin combination therapy ADR Adverse drug reaction AE Adverse event AL Artemether/lumefantrine ALT Alanine aminotransferase AST Aspartate aminotransferase AUC Area under the curve BP Blood pressure CI Confidence interval CQ Chloroquine CSR Clinical Study Report CYP Cytochrome P450 DBP Diastolic blood pressure DHA Dihydroartemisinin EU European Union FAF Fundus autofluorescence FDA Food and Drug Administration g Hb Gram of haemoglobin G6PD Glucose-6-phosphate dehydrogenase AusPAR Kozenis tafenoquine (as succinate) GlaxoSmithKline Australia Pty Ltd PM-2017-04578-1-2 Page 5 of 77 Final 15 November 2018 Therapeutic Goods Administration Abbreviation Meaning GCP Good Clinical Practice HPLC High pressure liquid chromatography L Litre MATE Multi antimicrobial extrusion protein mg Milligram mITT Modified Intent-to-Treat mL Millilitre OCT2 Organic cation transporter 2 OR Odds ratio Pf Plasmodium falciparum Pv Plasmodium vivax PC Placebo controlled PD Pharmacodynamic PI Product Information PK Pharmacokinetic(s) PP Per-protocol QTc Corrected QT interval QTcF Fridericia-corrected QT interval RBC Red blood cell SAE Serious adverse event SBP Systolic blood pressure SD Standard deviation SD-OCT Spectral domain optical coherence tomography SIL Stable isotope labelled SMQ Standardised MedDRA queries SOC System Organ Class AusPAR Kozenis tafenoquine (as succinate) GlaxoSmithKline Australia Pty Ltd PM-2017-04578-1-2 Page 6 of 77 Final 15 November 2018 Therapeutic Goods Administration Abbreviation Meaning TGA Therapeutic Goods Administration ULN Upper limit of normal US United States WHO World Health Organization Microgram μg AusPAR Kozenis tafenoquine (as succinate) GlaxoSmithKline Australia Pty Ltd PM-2017-04578-1-2 Page 7 of 77 Final 15 November 2018 Therapeutic Goods Administration I. Introduction to product submission Submission details Type of submission: New chemical entity Decision: Approved Date of decision: 12 September 2018 Date of entry onto ARTG: 13 September 2018 ARTG number: 297214 Yes. This product will remain in the scheme for 5 years, ‚Black Triangle Scheme starting on the date the product is first supplied in Australia. Active ingredient: Tafenoquine (as succinate) Product name: Kozenis Sponsor’s name and address: GlaxoSmithKline Australia Pty Ltd 436 Johnston Street, Abbotsford, VIC, 3067 Dose form: Film coated tablet Strength: 150 mg Container: Blister pack Pack size: 2 tablets Approved therapeutic use: Tafenoquine is indicated for the radical cure (prevention of relapse) of Pv malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for the acute
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