Auspar attachment 3: Extract from the Supplementary Clinical Evaluation Report for Daclizumab

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therapeutic goods administration


May 2017

AusPAR Attachment 3

Extract from the Supplementary Clinical Evaluation Report for Daclizumab

Proprietary Product Name: Zinbryta

Sponsor: Biogen Australia 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 the Extract from the Clinical Evaluation Report

This document provides a more detailed evaluation of the clinical findings, extracted from the Clinical Evaluation Report (CER) prepared by the TGA. This extract does not include sections from the CER regarding product documentation or post market activities.

The words [Information redacted], where they appear in this document, indicate that confidential information has been deleted.

For the most recent Product Information (PI), please refer to the TGA website .


© Commonwealth of Australia 2017

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 .


List of common abbreviations 6

1.Introduction 8

2.Clinical rationale 8

3.Contents of the clinical dossier 9

3.1.Scope of the clinical dossier 9

3.2.Paediatric data 10

3.3.Good clinical practice 10

4.Pharmacokinetics 10

5.Pharmacodynamics 10

6.Dosage selection for the pivotal studies 10

6.1.Dosage finding studies 10

6.2.Evaluator’s overall conclusions on dose selection 11

7.Clinical efficacy 11

7.1.Pivotal efficacy studies 11

7.1.1.Study 205MS201 11

7.1.2.Study 205MS301 32

7.2.Supplementary material submitted to the EMA in relation to pivotal efficacy data 54

7.2.1.EMA Question 70 54

7.2.2.EMA Question 94 62

7.2.3.EMA question 95 70

7.3.Other efficacy studies 74

7.4.Efficacy comparisons with other disease-modifying agents 74

7.5.Evaluator’s overall conclusions on clinical efficacy 75

8.Clinical safety 77

8.1.Summary of clinical safety from the CER 77

9.Supplementary safety data 78

9.1.Study MS201 79

9.2.Study MS301 80

9.3.Safety issues flagged in the US product information 81

9.3.1.Summary on first page 82

9.3.2.Complete boxed warning 82

9.4.Patient exposure 83

9.5.Post-marketing experience 83

9.6.Safety issues the potential for major regulatory impact 84

9.6.1.Liver toxicity 84

9.6.2.Hypersensitivity reactions 86

9.6.3.Infections 87

9.6.4.Haematology 88

9.6.5.Progressive Multifocal Leukoencephalopathy 91

9.7.Evaluator’s overall conclusions on clinical safety 92

10.First round benefit-risk assessment 94

10.1.First round assessment of benefits 94

10.2.First round assessment of risks 94

10.3.First round assessment of benefit-risk balance 94

11.First round recommendation regarding authorisation 96

11.1.Issues raised in the first round clinical evaluation report 96

11.1.1.Efficacy 96

11.1.2.Indications 96

11.1.3.Contraindications 98

11.1.4.Precautions 99

12.Clinical questions 100

12.1.Additional expert input 100

12.2.Efficacy 100

12.3.Safety 101

13.Second round evaluation of clinical data submitted in response to questions 102

14.References 102

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