Public Assessment Report. Decentralised Procedure. Tenofovir Zentiva 245 mg Film-coated Tablets. Tenofovir disoproxil fumarate UK/H/4970/001/DC

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1 Public Assessment Report Decentralised Procedure Tenofovir Zentiva 245 mg Film-coated Tablets Tenofovir disoproxil fumarate UK licence no: PL 17780/0573 Winthrop Pharmaceuticals UK Limited 1

2 LAY SUMMARY On 23 rd May 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) granted a Marketing Authorisation (licence) to Winthrop Pharmaceuticals UK Limited for the medicinal product Tenofovir Zentiva 245 mg Film-coated Tablets (PL 17780/0573, ). This is a prescription-only medicine (POM). Tenofovir 245 mg Film-coated Tablets contain the active substance tenofovir disoproxil fumarate. This active substance is an antiretroviral or antiviral medicine transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of enzymes (in HIV reverse transcriptase; in hepatitis B DNA polymerase) that are essential for the viruses to reproduce themselves. In HIV tenofovir should always be used combined with other medicines to treat HIV infection. Tenofovir is a treatment of HIV (Human Immunodeficiency Virus) infection. The tablets are suitable for : adults adolescents aged 12 to less than 18 years who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects. Tenofovir is also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus). The tablets are suitable for: adults adolescents aged 12 to less than 18 years. You do not have to have HIV to be treated with tenofovir for HBV. This medicine is not a cure for HIV infection. While taking tenofovir you may still develop infections or other illnesses associated with HIV infection. You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people. No new or unexpected safety concerns arose from this application and it was, therefore, judged that the benefits of taking Tenofovir Zentiva 245 mg Film-coated Tablets outweigh the risks. Hence a Marketing Authorisation has been granted. 2

3 TABLE OF CONTENTS Module 1: Information about initial procedure Page 4 Module 2: Summary of Product Characteristics Page 5 Module 3: Patient Information Leaflet Page 6 Module 4: Labelling Page 7 Module 5: Scientific Discussion Page 10 I. Introduction II. About the Product III. Scientific Overview and Discussion III.1. Quality aspects III.2. Non-clinical aspects III.3. Clinical aspects IV. Overall conclusion and Benefit-Risk Assessment Module 6 Steps taken after initial procedure Page 18 3

4 Module 1 Information about initial procedure Product Name Tenofovir 245 mg Film-coated Tablets Type of Application Generic, Article 10.1 Active Substance Form Strength MA Holder RMS CMS Procedure Numbers Tenofovir disoproxil fumarate Film-coated Tablets 245 mg Winthrop Pharmaceuticals UK Limited One Onslow Street Guildford Surrey GU1 4YS, UK UK Bulgaria, Czech Republic, Poland and Slovak Republic Timetable Day th April

5 Module 2 Summary of Product Characteristics In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPC) for products granted Marketing Authorisations at a national level are available on the MHRA website. 5

6 Module 3 Patient Information Leaflet In accordance with Directive 2010/84/EU the Patient Information Leaflets (PIL) for products granted Marketing Authorisations at a national level are available on the MHRA website. 6

7 Module 4 Labelling 7

8 8

9 9

10 Module 5 Scientific discussion during initial procedure I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the Reference Member State (RMS) and Concerned Member States (CMSs) considered that the application for Tenofovir Zentiva 245 mg Film-coated Tablets in the treatment of HIV-1 and HBV infection in adults, could be approved. This application was submitted under Article 10.1 of Directive 2001/83/EC (as amended). The applicant cross-refers to Viread 245 mg Film-coated Tablets (EM 16807/0007), first authorised to Gilead Sciences Int. Ltd, UK on 5 th February 2002 via the centralised procedure (EU/1/01/200/001). With the UK as the RMS in this Decentralised Procedure (), Winthrop Pharmaceuticals UK Limited applied for a Marketing Authorisation for Tenofovir Zentiva 245 mg Film-coated Tablets in Bulgaria, Czech Republic, Poland and Slovak Republic. Tenofovir disoproxil fumarate is the fumarate salt of the prodrug tenofovir disoproxil. Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate (nucleotide) analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate has an intracellular half-life of 10 hours in activated and 50 hours in resting peripheral blood mononuclear cells (PBMCs). Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination. Tenofovir diphosphate is a weak inhibitor of cellular polymerases α, β, and γ. At concentrations of up to 300 µmol/l, tenofovir has also shown no effect on the synthesis of mitochondrial DNA or the production of lactic acid in in vitro assays. No new non-clinical and clinical studies were conducted, which is acceptable given that the application was based on being generic medicinal product of originator product that has been licensed for over 10 years. A bioequivalence study was carried out in accordance with Good Clinical Practice (GCP). The RMS has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for these product types at all sites responsible for the manufacture and assembly of this product. For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites. For manufacturing sites outside the Community, the RMS has accepted copies of current GMP Certificates of satisfactory inspection summary reports, close-out letters or exchange of information issued by the inspection services of the competent authorities (or those countries with which the EEA has a Mutual Recognition Agreement for their own territories) as certification that acceptable standards of GMP are in place at those non-community sites. 10

11 The RMS considers that the Pharmacovigilance System as described by the applicant fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. Suitable justification has been provided for the non-submission of a Risk Management Plan (RMP). All involved Member States agreed to grant a Marketing Authorisation for the above product at the end of the procedure (Day th April 2013). After a subsequent national phase, the UK granted a Marketing Authorisation for this product on 23 rd May 2013 (PL 17780/0573). 11

12 II. ABOUT THE PRODUCT Name of the product in the Reference Member State Name(s) of the active substance(s) (INN) Pharmacotherapeutic classification (ATC code) Tenofovir 245 mg Film-coated Tablets Tenofovir disoproxil fumarate Antiviral for systemic use; nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF07 Pharmaceutical form and strength(s) Film-coated Tablets Reference numbers for the Decentralised Procedures Reference Member State United Kingdom Concerned Member States Bulgaria, Czech Republic, Poland and Slovak Republic Marketing Authorisation Number(s) PL 17780/0573 Name and address of the authorisation Winthrop Pharmaceuticals UK Limited holder One Onslow Street Guildford Surrey GU1 4YS, UK 12

13 III SCIENTIFIC OVERVIEW AND DISCUSSION III.1 QUALITY ASPECTS DRUG SUBSTANCE rinn: Tenofovir disoproxil fumarate Chemical Name: [[(1R)-2- (6 Amino - 9H purin -9-yl)-1-methylethoxy] methyl] phosphonic acid disoproxil fumarate Structure: (R)-9-(2-phosphonomethoxypropyl)adenine Disoproxil Fumarate Molecular Formula: C 19 H 30 N 5 O 10 P.C 4 H 4 O 4 Molecular Weight: g/mol Appearance: A white to an off-white crystalline powder Solubility: Sparingly soluble in Methanol and in Ethanol The drug substance is the subject of Active Substance Master File (ASMF). A letter of access has been provided by the drug substance manufacturer. Synthesis of the drug substance from the designated starting material(s) has been adequately described and appropriate in-process controls and intermediate specifications are applied. Satisfactory specification tests are in place for all starting materials and reagents, and these are supported by relevant Certificates of Analysis. An appropriate specification is provided for the drug substance. Analytical methods have been appropriately validated and are satisfactory for ensuring compliance with the relevant specifications. Certificates of Analysis for all working standards have been provided. Batch analysis data are provided, demonstrating compliance with the proposed specification. Satisfactory specifications and Certificates of Analysis have been provided for all packaging used to store the drug substance. Confirmation has been provided that the primary packaging complies with current guidelines concerning materials in contact with food. Appropriate stability data have been generated to support a suitable retest period when the drug substance is stored in the proposed packaging. DRUG PRODUCT Other Ingredients Other ingredients consist of the pharmaceutical excipients lactose monohydrate, povidone K- 25, croscarmellose sodium, microcrystalline cellulose (E-460), magnesium stearate making 13

14 up the tablet core and the film-coat consists of (Opadry II Light Blue Y A) lactose monohydrate, hypromellose (E-464), titanium dioxide (E-171), triacetin (E-1518) and indigo carmine aluminium lake (E-132) All excipients comply with their respective European Pharmacopoeia monographs except Opadry II Light Blue Y A which is covered by an in-house specification. Satisfactory Certificates of Analysis have been provided for all excipients. The only excipient used that contains material of animal or human origin is lactose monohydrate. The applicant has provided a declaration that the milk used in the production of lactose monohydrate is sourced from healthy animals under the same conditions as that for human consumption. Confirmation has also been given that the magnesium stearate used in the tablets is of vegetable origin. Pharmaceutical Development The objective of the development programme was to formulate robust, stable film-coated tablet that contains the same active ingredient as Viread 245 mg Film-coated Tablets (Gilead Sciences Int. Ltd, UK). A satisfactory account of the pharmaceutical development has been provided. Comparative impurity and dissolution profiles have been presented for the proposed and reference products. Manufacture Satisfactory batch formulae have been provided for the manufacture of the products, along with an appropriate account of the manufacturing process. The manufacturing process has been validated and has shown satisfactory results. Satisfactory process validation data on pilot-scale batches have been provided. The applicant has committed to perform process validation on future commercial-scale batches. Finished Product Specification The finished product specification is satisfactory. Test methods have been described and adequately validated. Batch data have been provided, which comply with the release specification. Certificates of Analysis have been provided for any working standards used. Container-Closure System The finished product is packed either in high density polyethylene (HDPE) bottle with a child-resistant cap and induction heat sealing (with aluminium foil), paper folding box. The bottle contains 30 film-coated tablets and a silica gel desiccant (in a container). Or OPA/Aluminium/PVC/Aluminium foil blisters, each containing 10 film-coated tablets, in one paper folding box. Specifications and Certificates of Analysis for all packaging materials have been provided. These are satisfactory. All primary packaging complies with relevant EU legislation regarding contact with food. 14

15 Stability Finished product stability studies have been conducted in accordance with current guidelines and in the packaging proposed for marketing. Based on the results, shelf-lives of 24 months for unopened container and 30 days after opening have been set. This medicinal product does not require any special storage conditions. These are satisfactory. Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling The SmPC, PIL and labelling are acceptable from a pharmaceutical perspective. User testing of the package leaflet has been accepted, based on a bridging report provided by the applicant, making reference to the user-testing of the PIL for Colistin Xellia 1 Million International Units (IU) powder for solution for infusion. The products are from the same therapeutic class and have similar indications. A critical analysis demonstrated that the key messages for safe and effective use of the products were similar for both leaflets. The justification of the rationale for bridging is accepted. The Marketing Authorisation Holder has committed to submit mock-ups for un-marketed pack sizes to the relevant regulatory authorities for approval before those packs are marketed. Marketing Authorisation Application (MAA) Forms The MAA form is satisfactory from a pharmaceutical perspective. Expert report The pharmaceutical expert report has been written by an appropriately qualified person and is a suitable summary of the pharmaceutical aspects of the dossier. Conclusion There are no objections to the approval of this product from a pharmaceutical point of view. III.2 NON-CLINICAL ASPECTS The pharmacodynamic, pharmacokinetic and toxicological properties of tenofovir disoproxil fumarate are well known. No new non-clinical data have been supplied with this application and none are required for applications of this type. The non-clinical expert report has been written by an appropriately qualified person and is a suitable summary of the non-clinical aspects of the dossier. Suitable justification has been provided for the non-submission of an environmental risk assessment. There are no objections to the approval of this product from a non-clinical point of view. III.3 CLINICAL ASPECTS In support of this application, the Marketing Authorisation holder has submitted the following bioequivalence study: This is a single centre, open label, randomised, single dose, two-way crossover bioequivalence study comparing Tenofovir 245 mg Film-coated Tablet (Zentiva, k.s., Czech Republic) with the reference product, Viread 245 mg Film-coated Tablet (Gilead 15

16 Sciences International Limited, CZ), in 40 healthy adult volunteers under fed conditions. Blood sampling performed pre-dosing and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 9.00, 12.0, 16.0, 24.0, 36.0, 48.0 and 72 hours post-dose in each period. The wash out period was 14 days. The main pharmacokinetic parameters (geometric mean) of tenofovir disoproxil fumarate (N = 40) PARAMETER INTRA- SUBJECT C.V. (%) GEOMETRIC LS MEANS * RATIO (%) 90% CONFIDENCE LIMITS (%) Test Reference Lower Upper C max AUC T * units are ng/ml for C max and ng.h/ml for AUC T The 90% confidence intervals for C max and AUC T were within the pre-defined limits. Bioequivalence has been shown for the test formulation (Tenofovir 245 mg Film-coated Tablets) and the reference formulation (Viread 245 mg Film-coated Tablets). Pharmacodynamics No new data have been submitted and none are required. Clinical Efficacy No new data have been submitted and none are required. Clinical Safety No new data have been submitted and none are required. Expert Report (Clinical Overall Summary) A clinical overall summary, written by an appropriately qualified physician, has been provided. This is a satisfactory, non-critical summary of Module 5. Module 1 Administrative information Marketing Authorisation Application forms (MAA) The MAA form is satisfactory from a clinical perspective. Summary of Product Characteristics (SmPC) The SmPC is satisfactory from a clinical perspective and consistent with that for the reference product. Patient Information Leaflet (PIL) The PIL is satisfactory from a clinical perspective and consistent with the SmPC. Packaging The packaging is satisfactory from a clinical perspective. Conclusion There are no objections to the approval of this product from a clinical point of view. 16

17 IV. OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT QUALITY The important quality characteristics of Tenofovir Zentiva 245 mg Film-coated Tablets are well-defined and controlled. The specifications and batch analytical results indicate consistency from batch to batch. There are no outstanding quality issues that would have a negative impact on the benefit/risk balance. NON-CLINICAL No new non-clinical data were submitted and none are required for applications of this type. EFFICACY Bioequivalence has been demonstrated between the applicant s Tenofovir 245 mg Filmcoated Tablet and the reference product, Viread 245 mg Film-coated Tablet. No new or unexpected safety concerns arose from this application. The SmPC and PIL are satisfactory and consistent with those for the reference product. Satisfactory labelling has been submitted. RISK-BENEFIT ASSESSMENT The quality of the product is acceptable and no new non-clinical or clinical safety concerns have been identified. Extensive clinical experience with tenofovir disoproxil fumarate is considered to have demonstrated the therapeutic value of the compound. The risk-benefit balance is considered to be positive. 17

18 Module 6 STEPS TAKEN AFTER INITIAL PROCEDURE - SUMMARY Date submitted Application type Scope Outcome 18

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