Australian public assessment for Albumin (human)

May 2017

Australian Public Assessment Report for Albumin (human)

Proprietary Product Name: Albunate 5, Albunate 20 and Albunate 25

Sponsor: CSL Limited

About the Therapeutic Goods Administration (TGA)

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  The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating medicines and medical devices.
  
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  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.
  
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  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.
  
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  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.
  
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  To report a problem with a medicine or medical device, please see the information on the TGA website .
  

About AusPARs

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  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.
  
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  AusPARs are prepared and published by the TGA.
  
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  An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations and extensions of indications.
  
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  An AusPAR is a static document; it provides information that relates to a submission at a particular point in time.
  
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  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 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 .

Contents

Common abbreviations 5

I. Introduction to product submission 7

Submission details 7

Product background 7

Regulatory status 8

Product Information 8

II. Quality findings 9

Drug substance (active ingredient) 9

Drug product 10

Quality summary and conclusions 10

III. Nonclinical findings 11

IV. Clinical findings 11

Introduction 11

Pharmacokinetics 15

Pharmacodynamics 15

Dosage selection for the pivotal studies 16

Efficacy 16

Safety 19

First round benefit-risk assessment 24

First round recommendation regarding authorisation 24

Clinical questions 24

Second round evaluation of clinical data submitted in response to questions 25

V. Pharmacovigilance findings 25

Risk management plan 25

VI. Overall conclusion and risk/benefit assessment 30

Introduction 30

Quality 31

Nonclinical 31

Clinical 31

Risk management plan 34

Risk-benefit analysis 35

Outcome 43

Attachment 1. Product Information 44

Attachment 2. Extract from the Clinical Evaluation Report 44

Common abbreviations

Abbreviation	Meaning
ADR		Adverse drug reaction
APTT		activated partial thromboplastin time
ARCBS		Australian Red Cross Blood Service
ASA		Australian Specific Annex (to the RMP)
BPWP		Blood Products Working Party
CI		Confidence interval
CMI		Consumer Medicine Information
COP		Colloid osmotic or oncotic pressure
CSL		CSL Limited
DHCPL		dear health care provider letter
EMA		European Medicines Agency
EMEA		European Medicines Evaluations Agency
EU		European Union
GMP		Good Manufacturing Practice
HAS		Human Albumin Solution
HSA		Human serum albumin
HES		Hydroxyethyl starch
ICH		International Conference on Harmonisation
ICU		Intensive care unit
IV		intravenous
LBS		literature based submission
MedDRA		Medical dictionary for regulatory affairs
NBA		National Blood Authority
Ph.Eur.		European Pharmacopoeia
PMF		Plasma Master File
PSUR		Periodic Safety Update Report
RCT		Randomised controlled trial
RMP		Risk Management Plan
RR		Relative risk
SPC		Summary of Product Characteristics
SOC		System organ class
TGA		Therapeutic Goods Administration
USA		United States of America