June 2016 Australian Public Assessment Report for Elvitegravir / Cobicistat / Emtricitabine / Tenofovir alafenamide (as fumarate) Proprietary Product Name: Genvoya Sponsor



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June 2016
Australian Public Assessment Report for Elvitegravir / Cobicistat / Emtricitabine / Tenofovir alafenamide (as fumarate)

Proprietary Product Name: Genvoya

Sponsor: Gilead Sciences Pty Ltd

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 .

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 2016


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 .
Contents

Common abbreviations 7

I. Introduction to product submission 10

Submission details 10

Product background 11

Regulatory status 13

Product Information 14

II. Quality findings 14

Introduction 14

Active ingredients 14

Drug product 16

Biopharmaceutics 18

Quality summary and conclusions 21



III. Nonclinical findings 22

Introduction 22

Pharmacology 23

Pharmacokinetics 26

Toxicology 29

Nonclinical summary and conclusions 45



IV. Clinical findings 63

Clinical rationale 63

Pharmacokinetics 66

Pharmacodynamics 68

Dosage selection for the pivotal studies 69

Efficacy 70

Safety 71

First round benefit-risk assessment 75

First round recommendation regarding authorisation 81

Clinical questions 81



V. Pharmacovigilance findings 81

Risk management plan 81



VI. Overall conclusion and risk/benefit assessment 90

Quality 90

Nonclinical 91

Clinical 92

Risk management plan 117

Risk-benefit analysis 118



Outcome 132

Attachment 1. Product Information 133

Attachment 2. Extract from the Clinical Evaluation Report 133



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