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Australian Public Assessment Report for Pitavastatin

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Australian Public Assessment Report for Pitavastatin Proprietary Product Name: Livalo Sponsor: Abbott Australasia Pty Ltd September 2013 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 <http://www.tga.gov.au>. About AusPARs · An Australian Public Assessment Record (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, in that it will provide 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 2013 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 Livalo Pitavastatin Abbott Australasia Pty Ltd PM-2010-02898-3-3 2 of 128 Date of finalisation 2 September 2013 Therapeutic Goods Administration Contents I. Introduction to product submission _____________________________________ 4 Submission details ____________________________________________________________________ 4 Product background __________________________________________________________________ 4 Regulatory status _____________________________________________________________________ 5 Product Information__________________________________________________________________ 5 II. Quality findings _____________________________________________________________ 5 Drug substance (active ingredient) _________________________________________________ 5 Drug product __________________________________________________________________________ 6 Bioavailability _________________________________________________________________________ 6 Quality summary and conclusions __________________________________________________ 9 III. Nonclinical findings _______________________________________________________ 9 Introduction ___________________________________________________________________________ 9 Pharmacology _________________________________________________________________________ 9 Pharmacokinetics ____________________________________________________________________ 12 Toxicology ____________________________________________________________________________ 16 Nonclinical summary ________________________________________________________________ 24 Conclusions and recommendations ________________________________________________ 25 IV. Clinical findings __________________________________________________________ 26 Introduction __________________________________________________________________________ 26 Pharmacokinetics ____________________________________________________________________ 27 Pharmacodynamics__________________________________________________________________ 46 Efficacy _______________________________________________________________________________ 49 Safety _________________________________________________________________________________ 86 List of questions ___________________________________________________________________ 103 Clinical summary and conclusions _______________________________________________ 104 V. Pharmacovigilance findings ___________________________________________111 Risk management plan ____________________________________________________________ 111 VI. Overall conclusion and risk/benefit assessment _________________113 Quality ______________________________________________________________________________ 114 Nonclinical _________________________________________________________________________ 114 Clinical ______________________________________________________________________________ 114 Risk management plan ____________________________________________________________ 122 Risk-benefit analysis ______________________________________________________________ 122 Outcome ____________________________________________________________________________ 127 Attachment 1. Product Information _____________________________________127 AusPAR Livalo Pitavastatin Abbott Australasia Pty Ltd PM-2010-02898-3-3 3 of 128 Date of finalisation 2 September 2013 Therapeutic Goods Administration I. Introduction to product submission Submission details Type of submission: New Chemical Entity Decision: Approved Date of Decision: 25 November 2011 Active ingredients: Pitavastatin Product names: Livalo Sponsor’s name and address: Abbott Australasia Pty Ltd Locked Bag 5016 Botany NSW 1455 Dose form: Film-coated tablets Strengths: 1 mg, 2 mg and 4 mg [of free base] Containers: Polyvinylidene chloride (PVdC) coated polyvinyl chloride (PVC) and aluminium blisters Pack sizes: 10, 30 and 100 tablets Approved therapeutic use: Livalo is indicated as an adjunct to diet for the treatment of adult patients with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, when response to diet and other non-pharmacological measures is inadequate. Prior to initiating therapy with Livalo, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Route of administration: Oral (PO) Dosage: See Product Information (PI) Attachment 1. ARTG Numbers: 176640, 176658 and 176659 Product background This AusPAR describes the application by Abbott Products (Australia) Pty Ltd to register a new chemical entity, pitavastatin calcium (Livalo), for use as a hypolipidaemic agent. Pitavastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor AusPAR Livalo Pitavastatin Abbott Australasia Pty Ltd PM-2010-02898-3-3 4 of 128 Date of finalisation 2 September 2013 Therapeutic Goods Administration or ‘statin’ and is structurally related to other HMG-CoA reductase inhibitors such as the marketed drugs lovastatin, simvastatin, pravastatin, fluvastatin, atorvastatin and rosuvastatin. There are two TGA adopted European guidelines relevant to this submission, besides the general guidelines, which are cited throughout this AusPAR: CPMP/EWP/3020/03: Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders. Effective: 20 May 2005 EMEA/CHMP/EWP/350495/2009: Concept Paper on the Need to Update the Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (CPMP/EWP/3020/03) Regulatory status Pitavastatin has been approved in Japan (2003), Europe (UK and The Netherlands, August 2010) and USA (August 2009). The approved indications are as follows: Europe Livazo is indicated for the reduction of elevated total cholesterol (TC) and LDL-C, in adult patients with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia, and combined (mixed) dyslipidaemia, when response to diet and other non-pharmacological measures is inadequate. USA Livalo is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Product Information The approved product information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. II. Quality findings Drug substance (active ingredient) Figure 1a shows the chemical structure of pitavastatin calcium. Full and adequate details of the synthesis and control were provided in the form of a drug
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