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Auspar Attachment 2: Extract from the Clinical Evaluation Report for Ulipristal Acetate

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Auspar Attachment 2: Extract from the Clinical Evaluation Report for Ulipristal Acetate AusPAR Attachment 2 Extract from the Clinical Evaluation Report for ulipristal acetate Proprietary Product Name: EllaOne Sponsor: ERA Consulting (Australia) Pty Ltd Date of CER: 31 July 2014 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. The 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 <www.tga.gov.au>. 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 <www.tga.gov.au/product-information-pi>. Copyright © Commonwealth of Australia 2015 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]>. Submission PM-2013-04154-1-5 Extract from the Clinical Evaluation Report for EllaOne 2 of 31 Therapeutic Goods Administration Contents List of abbreviations __________________________________________________________ 5 1. Clinical rationale _________________________________________________________ 7 2. Contents of the clinical dossier ________________________________________ 7 2.1. Scope of the clinical dossier _________________________________________________ 7 2.2. Paediatric data _______________________________________________________________ 7 2.3. Good clinical practice ________________________________________________________ 7 3. Pharmacokinetics ________________________________________________________ 7 3.1. Studies providing pharmacokinetic data __________________________________ 7 3.2. Summary of pharmacokinetics _____________________________________________ 8 3.3. Evaluator’s conclusions on pharmacokinetics __________________________ 11 4. Pharmacodynamics ____________________________________________________ 12 4.1. Studies providing pharmacodynamic data ______________________________ 12 4.2. Summary of pharmacodynamics _________________________________________ 12 4.3. Evaluator’s conclusions on pharmacodynamics ________________________ 14 5. Dosage selection for the pivotal studies ___________________________ 14 5.1. Study HRA2914-507 _______________________________________________________ 14 5.2. Study HRA2914-508 _______________________________________________________ 16 5.3. Conclusions with regard to the dose finding studies ___________________ 16 6. Clinical efficacy _________________________________________________________ 17 6.1. Emergency contraception _________________________________________________ 17 6.2. Evaluator’s conclusions on efficacy for emergency contraception ____ 22 7. Clinical safety ___________________________________________________________ 23 7.1. Studies providing safety data _____________________________________________ 23 7.2. Studies providing evaluable safety data _________________________________ 23 7.3. Pivotal studies that assessed safety as a primary outcome ____________ 24 7.4. Patient exposure ___________________________________________________________ 24 7.5. Adverse events _____________________________________________________________ 24 7.6. Laboratory tests ___________________________________________________________ 26 7.7. Post-marketing experience _______________________________________________ 27 7.8. Safety issues with the potential for major regulatory impact __________ 28 7.9. Evaluator’s conclusions on safety ________________________________________ 29 8. First round benefit-risk assessment ________________________________ 29 8.1. First round assessment of benefits _______________________________________ 29 8.2. First round assessment of risks __________________________________________ 30 Submission PM-2013-04154-1-5 Extract from the Clinical Evaluation Report for EllaOne 3 of 31 Therapeutic Goods Administration 8.3. First round assessment of benefit-risk balance _________________________ 30 9. First round recommendation regarding authorisation _________ 30 10. Clinical questions ____________________________________________________ 30 Submission PM-2013-04154-1-5 Extract from the Clinical Evaluation Report for EllaOne 4 of 31 Therapeutic Goods Administration List of abbreviations Abbreviation Meaning AE Adverse Event ALT Alanine aminotransferase AST Aspartate aminotrasferase AUC Area Under the Curve AUC0-inf Area Under the plasma concentration time Curve from time 0 to infinity AUC0-t Area Under the plasma concentration time Curve from time 0 to last observation CL/F Clearance divided by bioavailablity (plasma clearance of an orally administered dose) Cmax Maximum plasma concentration CV Coefficient of Variability DAE Adverse Event leading to Discontinuation EC Emergency Contraception HCP Health Care Professional HSUP High Sensitivity Urine Pregnancy test ITT Intention To Treat IUD Intra-Uterine Device LH Lutenising Hormone mITT modified Intention To Treat PI Product Information document PD Pharmacodynamics PK Pharmacokinetics SAE Serious Adverse Event SD Standard Deviation Submission PM-2013-04154-1-5 Extract from the Clinical Evaluation Report for EllaOne 5 of 31 Therapeutic Goods Administration Abbreviation Meaning SE Standard Error SPRM Selective Progesterone Receptor Modulator TEAE Treatment Emergent Adverse Event t½ Half-life Tmax Time to maximum plasma concentration UPI Un-Protected Intercourse Submission PM-2013-04154-1-5 Extract from the Clinical Evaluation Report for EllaOne 6 of 31 Therapeutic Goods Administration 1. Clinical rationale There is a clinical need for the availability of emergency contraception because of the health and social costs of unplanned pregnancy. Unplanned pregnancy may result from contraception failure or situations where intercourse is not anticipated or has been coerced. Abortion is a less acceptable alternative to emergency contraception. High dose oestrogen progestin regimens, and more recently levonorgestrel, have been previously used as emergency contraception. However, with levonorgestrel reported pregnancy rates rise from approximately 1.5 to 2.6%, respectively, for intake 0 to 24 h as compared to intake 48 to 72 h after intercourse. Hence, ulipristal offers the potential for emergency contraception that can be taken within 5 days of UPI. 2. Contents of the clinical dossier 2.1. Scope of the clinical dossier The submission contained the following clinical information: • 19 clinical pharmacology studies, including 14 that provided pharmacokinetic data and 6 that provided pharmacodynamic data; • No population pharmacokinetic analyses; • One pivotal efficacy/safety study; • Two dose finding studies; • Two other efficacy/safety studies; • Four pooled analyses, seven periodic safety update reports (PSURs), and one postmarketing study. 2.2. Paediatric data The submission included data for females aged 13 years and over. The sponsor has an approved paediatric investigation plan (PIP) that includes adolescent girls aged 12 to 17 years. The s menarchic girls are not considered to be at risk of pregnancy. ponsor has a waiver for children aged ≤12 years because pre 2.3. Good clinical practice The clinical studies were stated, and appeared, to have been conducted according to Good Clinical Practice. 3. Pharmacokinetics 3.1. Studies providing pharmacokinetic data Table 1 shows the studies relating to each pharmacokinetic topic and the location of each study summary. Submission PM-2013-04154-1-5 Extract from the Clinical Evaluation Report for EllaOne 7 of 31 Therapeutic Goods Administration Table 1: Submitted pharmacokinetic studies. None of the pharmacokinetic studies had deficiencies that excluded their results from consideration.
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