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Australian Public Assessment Report for Clobetasol Propionate

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Australian Public Assessment Report for Clobetasol Propionate Australian Public Assessment Report for Clobetasol propionate Proprietary Product Name: Clobex Sponsor: Galderma Australia Pty Ltd May 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 Ageing, and is responsible for regulating medicines and medical devices. • 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]>. Page 2 of 45 AusPAR Clobex clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5 Final 22 May 2013 Therapeutic Goods Administration Contents I. Introduction to product submission _____________________________________ 5 Submission details ____________________________________________________________________ 5 Product background __________________________________________________________________ 5 Regulatory status _____________________________________________________________________ 6 Product Information__________________________________________________________________ 7 List of abbreviations __________________________________________________________________ 7 II. Quality findings _____________________________________________________________ 8 Drug substance (active ingredient) _________________________________________________ 8 Drug product __________________________________________________________________________ 8 Biopharmaceutics ____________________________________________________________________ 9 Advisory committee considerations _______________________________________________ 10 Quality summary and conclusions _________________________________________________ 11 III. Nonclinical findings _____________________________________________________ 11 Introduction __________________________________________________________________________ 11 Pharmacology ________________________________________________________________________ 12 Pharmacokinetics ____________________________________________________________________ 13 Toxicology ____________________________________________________________________________ 15 Nonclinical summary and conclusions _____________________________________________ 21 IV. Clinical findings __________________________________________________________ 23 Introduction __________________________________________________________________________ 23 Pharmacokinetics ____________________________________________________________________ 24 Pharmacodynamics__________________________________________________________________ 25 Phase II studies ______________________________________________________________________ 25 Efficacy _______________________________________________________________________________ 25 Safety _________________________________________________________________________________ 27 Clinical summary and conclusions _________________________________________________ 28 V. Pharmacovigilance findings ____________________________________________ 30 Risk management plan ______________________________________________________________ 30 VI. Overall conclusion and risk/benefit assessment __________________ 31 Quality ________________________________________________________________________________ 31 Nonclinical ___________________________________________________________________________ 32 Clinical ________________________________________________________________________________ 33 Risk management plan ______________________________________________________________ 36 Risk-benefit analysis ________________________________________________________________ 36 Outcome ______________________________________________________________________________ 43 Page 3 of 45 AusPAR Clobex clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5 Final 22 May 2013 Therapeutic Goods Administration Attachment 1. Product Information ____________________________________ 44 Attachment 2. Extract from the Clinical Evaluation Report __________ 44 Page 4 of 45 AusPAR Clobex clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5 Final 22 May 2013 Therapeutic Goods Administration I. Introduction to product submission Submission details Type of Submission: New Chemical Entity Decision: Approved Date of Decision: 6 February 2013 Active ingredient: Clobetasol propionate Product Name: Clobex Sponsor’s Name and Address: Galderma Australia Pty Ltd 13B Narabang Way Belrose NSW 2085 Dose form: Shampoo Strength: Container(s): Bottle500 μg/g Pack size: 4, 8 or 16 doses of 7.5 mL (30, 60 and 125 mL bottles) Approved Therapeutic use: Topical treatment of moderate to severe scalp psoriasis in adults. Route of administration: Topical Dosage: 3.75 mg (7.5 mL) once daily ARTG Number: 188346 Product background This AusPAR describes the application by Galderma Australia Pty Ltd to register a new chemical entity, clobetasol proprionate (0.05%; 500 µg/g; Clobex), originally as both a spray or shampoo formulation for the topical treatment of moderate to severe plaque-type or scalp psoriasis, respectively. The application to register Clobex topical spray solution was withdrawn by the sponsor on the 23 of October 2012. Thus, this document will not refer to the spray submission. Clobetasol propionate (CP) bears structural similarity to other betamethasone-type corticosteroids including betamethasone, dexamethasone and fluocortolone. Clobetasol propionate (CP) was previously registered on the Australian Register for Therapeutic Goods (ARTG) as Dermovate. This range has been delisted from the ARTG so, as advised by the TGA, in this proposed application,clobetasol-17-propionate will be classified as a new chemical entity (NCE). It has been marketed overseas (USA and Europe) for over 20-30 years and has been widely available for topical administration at a concentration of 0.05% in several dosage forms (including ointment, cream, solution and gel) for use in inflammatory diseases. The sponsor requested the following indications: Page 5 of 45 AusPAR Clobex clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5 Final 22 May 2013 Therapeutic Goods Administration Topical treatment of moderate to severe scalp psoriasis in adults. with the following dosing regimen: (Abridged) “Clobex Shampoo: Should be applied directly on dry scalp once daily taking care to well cover and massage the lesions. An amount equivalent to approximately one and a half teaspoons (approximately 7.5 mL) per application is sufficient to cover all the scalp. Clobex shampoo should be then kept in place without covering for 15minutes before rinsing.... Treatment duration should be limited to a maximum of 4 weeks. As soon as clinical results are observed, applications should be spaced out or replaced, if needed, by an alternative treatment. Repeated courses of Clobex Shampoo may be used to control exacerbations provided the patient is Under regular supervision”. Regulatory status The following table summarises the international regulatory status for this product. Table 1. Summary of the international regulatory status of Clobex shampoo Country* Local Registration Indication Product Date Name Clobex Shampoo (clobetasol propionate Canada Clobex 29 July
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