LOSARTAN POTASSIUM 12.5, 25MG, 50MG & 100MG FILM- COATED TABLETS PL 14017/ UKPAR TABLE OF CONTENTS

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1 LOSARTAN POTASSIUM 12.5, 25MG, 50MG & 100MG FILM- COATED TABLETS PL 14017/ UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 5 Steps taken for assessment Page 16 Summary of Product Characteristics Page 17 Product Information Leaflet Page 18 Labelling Page 19 1

2 LAY SUMMARY Losartan Potassium 12.5mg, 25mg, 50mg and 100mg film-coated tablets (losartan potassium, film-coated tablets, 12.5mg, 25mg, 50mg and 100mg) This is a summary of the Public Assessment Report (PAR) for Losartan Potassium 12.5mg film-coated tablets (PL 14017/0140), Losartan Potassium 25mg film-coated tablets (PL 14017/0141), Losartan Potassium 50mg film-coated tablets (PL 14017/0142) and Losartan Potassium 100mg film-coated tablets (PL 14017/0143). It explains how Losartan Potassium 12.5mg, 25mg, 50mg and 100mg film-coated Tablets were assessed and their authorisation recommended, as well as their conditions of use. It is not intended to provide practical advice on how to use Losartan Potassium 12.5mg, 25mg, 50mg and 100mg film-coated tablets. These products will collectively be referred to as Losartan Tablets throughout the remainder of this public assessment report. For practical information about using Losartan Tablets, patients should read the package leaflet or contact their doctor or pharmacist. What are Losartan Tablets and what are they used for? Losartan Tablets are generic medicines. This means that Losartan Tablets are similar to a reference medicine already authorised in the European Union (EU) called Cozaar 12.5mg, 25mg, 50mg & 100mg film coated tablets (Merck Sharp & Dohme, BV). Losartan Tablets are used: to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6-18 years of age. to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria 0.5 g per day (a condition in which urine contains an abnormal amount of protein). to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by the patient s doctor. If the patient s heart failure has been stabilised with an ACE inhibitor, the patient should not be switched to losartan. in patients with high blood pressure and a thickening of the left ventricle, Losartan Tablets have been shown to decrease the risk of stroke ( LIFE indication ). How do Losartan Tablets work? Losartan belongs to a group of medicines known as angiotensin-ii receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-ii to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.. 2

3 How are Losartan Tablets used? The pharmaceutical form of Losartan Tablets is a film-coated tablet and the route of administration is by mouth (oral). The patient must always take Losartan Tablets exactly as their doctor has told them to. The patient must check with their doctor or pharmacist if they are not sure. The patient s doctor will decide on the appropriate dose of Losartan tablets, depending on the patient s condition and whether the patient is taking other medicines. It is important that the patient continues to take Losartan Tablets for as long as the patient s doctor prescribes it in order to maintain smooth control of the patient s blood pressure. The tablets should be swallowed with a glass of water. The patient should try to take their daily dose at about the same time each day. It is important that the patient continues to take Losartan tablets until the patient s doctor tells them otherwise. Please read section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration, and the duration of treatment. This medicine can only be obtained with a prescription. What benefits of Losartan Tablets, have been shown in studies? As Losartan Tablets are generic medicines, studies in patients have been limited to tests to determine that the tablets are similar to the reference medicine, Lorzaar Protect 12.5 mg, 25 mg, 50 mg and 100 mg, marketed in Germany (Merck Sharp Dohme Ltd, UK). It has been confirmed that the UK reference product Cozaar 12.5mg, 25mg, 50mg & 100mg film coated tablets (Merck Sharp & Dohme, BV) and Lorzaar Protect 12.5 mg, 25 mg, 50 mg and 100 mg (Merck Sharp Dohme Ltd, UK) taken from the German market are the same. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. What are the possible side effects of Losartan Tablets? Because Losartan Tablets are generic medicines, their benefits and possible side effects are taken as being the same as the reference medicine. For the full list of all side effects reported with Losartan Tablets, see section 4 of the package leaflet available on the MHRA website. Why was Losartan Tablets, approved? It was concluded that, in accordance with EU requirements, Losartan Tablets, have been shown to have comparable quality and to be bioequivalent to Cozaar 12.5mg, 25mg, 50mg & 100mg film coated tablets (Merck Sharp & Dohme, BV). Therefore, the MHRA decided that, as for Cozaar 12.5mg, 25mg, 50mg & 100mg film coated tablets (Merck Sharp & Dohme, BV) the benefits are greater than the risks and recommended that it can be approved for use. 3

4 What measures are being taken to ensure the safe and effective use of Losartan tablets? Safety information has been included in the Summary of Product Characteristics and the package leaflet for Losartan Tablets, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously. Other information about Losartan Tablets Marketing Authorisations were granted in the UK on 19 June The full PAR for Losartan Tablets follows this summary. For more information about treatment with Losartan Tablets read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in May

5 LOSARTAN POTASSIUM 12.5 MG, 25MG, 50MG & 100MG FILM-COATED TABLETS PL 14017/ SCIENTIFIC DISCUSSION TABLE OF CONTENTS I. Introduction Page 6 II. Quality aspects Page 7 III. Non-clinical aspects Page 10 IV. Clinical aspects V. User consultation VI. Overall conclusion and risk/benefit assessment and recommendations Page 11 Page 15 Page 15 Steps taken after authorisation Page 23 Annex 1 Page 24 5

6 I. INTRODUCTION Based on the review of the data on quality, safety and efficacy, the MHRA granted Dexcel Pharma Limited Marketing Authorisations for the medicinal product Losartan Tablets (PL 14017/0140-3) on 19 th June This is a prescription-only medicine used to treat patients with high blood pressure (hypertension); to protect the kidney in hypertensive type 2 diabetic patients with proteinuria 0.5 g/day as part of an antihypertensive treatment; to treat adult patients with chronic heart failure when therapy with Angiotensin-converting-enzyme inhibitors (ACE inhibitors) is not considered suitable and in patients with high blood pressure and a thickening of the left ventricle. Losartan Tablets contains the active ingredient, losartan potassium. Losartan belongs to a group of medicines known as angiotensin-ii receptor antagonists. These are national, abridged applications, submitted according to Article 10.1 of Directive 2001/83/EC, and have been shown to be generic medicinal products of the originator Cozaar 12.5mg, 25mg, 50mg & 100mg film coated tablets (Merck Sharp & Dohme, BV). The reference products were licensed in Denmark on 26 th September 1994 and so the 10-year period of data exclusivity has expired. These applications were submitted at the same time and depend on the bioequivalence study comparing the applicant s 100mg product with the reference product Lorzaar Protect 100mg marketed in Germany, manufactured in UK by Merck Sharp Dohme Ltd.). Consequently, all sections of this Scientific Discussion refer to all four products. 6

7 II. QUALITY ASPECTS (ii) DRUG SUBSTANCE Losartan potassium Nomenclature: INN: Losartan potassium Chemical name: 2-butyl-4-chloro-1-[p-(o-1H-tetrazole-5-ylphenyl)benzyl]- imidazole-5-methanol, monopotassium salt 2-n-butyl-4-chloro-5-hydroxymethyl-1-[[(2 -(1H-tetrazol-5-yl)biphenyl-4- yl[methyl] imidazole, monopotassium salt Structure: N Cl N CH 2 OH N N NK N Molecular formula: C 22 H 22 ClKN 6 O Molecular weight: Physical form: Solubility: White to off-white crystalline powder. Freely soluble in water and very slightly soluble in acetonitrile. Synthesis of the drug substance from the designated starting material has been adequately described and appropriate in-process controls and intermediate specifications are applied. Satisfactory specifications 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 active substance losartan potassium. Analytical methods have been appropriately validated and are satisfactory for ensuring compliance with the relevant specifications. Active losartan potassium is stored in appropriate packaging that comply with Directive 2002/72/EC (as amended), and are suitable for contact with foodstuffs. Specifications and certificates of analysis have been provided. Batch analysis data are provided and comply with the proposed specification. Satisfactory certificates of analysis have been provided for standards used by the active substance manufacturer during validation studies. 7

8 Appropriate stability data have been generated for drug substance stored in the same immediate packaging as the commercial packaging. The data demonstrates the stability of the drug substance and supports an appropriate retest period when stored in the proposed packaging. MEDICINAL PRODUCT Other ingredients Other ingredients consist of pharmaceutical excipients, namely lactose monohydrate, starch pre-gelatinized, silica colloidal anhydrous, microcrystalline cellulose, magnesium stearate. All the ingredients within the tablet core comply with relevant Ph Eur monographs. The tablet coating ingredients consist of carnauba wax and Opadry 03B28796 White which consists of hypromellose, titanium dioxide (E171) and macrogol. All the ingredients within the tablet coating comply with relevant Ph Eur monographs. Appropriate justification for the inclusion of each excipient has been provided. Satisfactory certificates of analysis have been provided for all excipients. There were no novel excipients used. Pharmaceutical development Details of the pharmaceutical development of the drug products have been supplied and are satisfactory. Dissolution and impurity profiles Dissolution and impurity profiles of the drug products were found to be similar to those for the reference products. Manufacture A description and flow-chart of the manufacturing method has been provided. In-process controls have been provided and are appropriate considering the nature of the product and the method of manufacture. Process validation has been carried out on five validation batches. The results are satisfactory. Finished product specification The finished product specification is satisfactory. Acceptance limits have been justified with respect to conventional pharmaceutical requirements and, where appropriate, safety. Test methods have been described and have been adequately validated, as appropriate. Batch data have been provided and comply with the release specification. Certificates of analysis have been provided for any standards used. Container Closure System The tablets are packed in white, opaque PVDC (polyvinylidene chloride) - coated PVC (polyvinylchloride) blisters sealed with aluminium foil. Specifications and Certificates of Analysis for all packaging types used have been provided. These are satisfactory. All primary product packaging complies with EU legislation, Directive 2002/72/EC, regarding contact with food. The product is packaged in sizes of 28, tablets. 8

9 Stability Finished product stability studies have been conducted in accordance with current guidelines and results were within the proposed specification limits. Based on the results, a shelf-life of 3 years has been set, which is satisfactory. Storage conditions are Store in original package. Discussion on chemical, pharmaceutical and biological aspects The grounds for this application are considered adequate. It is recommended that Marketing Authorisations are granted for these applications. 9

10 III. NON-CLINICAL ASPECTS No new non-clinical data have been supplied with this application and none are required for an application of this type. A preclinical expert report has been written by a suitably qualified person and is satisfactory. 10

11 IV. CLINICAL ASPECTS CLINICAL PHARMACOLOGY PHARMACOKINETICS Absorption Following oral administration, losartan is well absorbed and undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites. The systemic bioavailability of losartan tablets is approximately 33%. Mean peak concentrations of losartan and its active metabolite are reached in 1 hour and in 3-4 hours, respectively. Distribution Both losartan and its active metabolite are 99% bound to plasma proteins, primarily albumin. The volume of distribution of losartan is 34 L. Metabolism About 14% of an orally-administered dose of losartan is converted to its active metabolite (carboxylosartan) by CYP2C9 and CYP3A4. The active metabolite is fold more potent than the parent drug. In addition to the active metabolite, inactive metabolites are formed. Excretion When losartan is administered orally, about 4% of the dose is excreted unchanged in the urine, and about 6% of the dose is excreted in the urine as active metabolite. The pharmacokinetics of losartan and its active metabolite are linear with oral losartan potassium doses up to 200 mg. Following oral administration, plasma concentrations of losartan and its active metabolite decline polyexponentially with a terminal half-life of about 2 hours and 6-9 hours, respectively. During once-daily dosing with 100 mg, neither losartan nor its active metabolite accumulate significantly in plasma. Special populations In elderly hypertensive patients the plasma concentrations of losartan and its active metabolite do not differ essentially from those found in young hypertensive patients. In female hypertensive patients the plasma levels of losartan were up to twice as high as in male hypertensive patients, while the plasma levels of the active metabolite did not differ between men and women. Following oral administration in patients with mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of losartan and its active metabolite were, respectively, 5-fold and 1.7-fold greater than those seen in young male volunteers. Plasma concentrations of losartan are not altered in patients with creatinine clearance above 10 ml/min. Compared to patients with normal renal function, the AUC for losartan is approximately 2-fold greater in haemodialysis patients. Plasma concentrations of the active metabolite are not altered in patients with renal impairment or in haemodialysis patients. Neither losartan nor the active metabolite can be removed by haemodialysis. 11

12 Assessor s overall conclusions on pharmacokinetics To demonstrate bioequivalence the prodrug should be measured. Levels of the active metabolite may also be measured to provide further confirmation of bioequivalence. Conventional bioequivalence acceptance criteria apply to this drug substance (80-125% for C max and AUC) and absorption kinetics are linear over a dose range of 12.5 mg to 200 mg for losartan potassium. BIOEQUIVALENCE Pharmaceutical details The reference product is Lorzaar Protect 100 mg, marketed in Germany, manufactured in UK by Merck Sharp Dohme Ltd. The test product was Dexcel s losartan potassium 100 mg tablets. The batch size represents 10% of the maximum production batch size and is acceptable. The test product is considered to be representative of the product proposed for marketing. Satisfactory Certificates of Analysis for the test and reference products were provided. Justification for biowaivers A biostudy was only performed using the 100 mg strength and this was acceptable as adequate evidence was provided that all of the criteria in the Note for Guidance (CPMP/EWP/QWP1401/98) were met and the pharmacokinetics of losartan are linear over the proposed 12.5mg, 25 mg and 50 mg strength tablets. This was adequately justified in the clinical expert report. Essential Similarity Comparative dissolution and impurity profiles of the test and reference products from the UK were provided and can be considered essentially similar. Furthermore, bioequivalence has been demonstrated using a pilot-scale batch of losartan potassium 100 mg tablets and this study is sufficient to show essential similarity of the other three lower strengths. Bioanalytical methods and validation Losartan and losartan carboxylosartan were analysed using a HPLC-MS/MS method following solid phase extraction. The range of the calibration curves for losartan and carboxylosartan were 2.00 ng/ml to ng/ml and 2.50 ng/ml to ng/ml respectively. In-process validation was accomplished using calibration curves and QC samples. Pre-study validation reports have also been provided. Method specificity, linearity, and sample stability have been demonstrated and studies on inter- and intra-assay precision and accuracy, including determination of the limit of quantitation for losartan and carboxylosartan have been performed. Losartan-d 4 and Losartan Acid-d 4 were used as the internal standard. Data indicate that the method is suitable for the determination of both analytes. The validated range of the assay is satisfactory. Assessment of Study Protocol Study design This was a single center, randomized, single-dose, open-label, 2-way crossover bioequivalence, performed under fasting conditions. Subjects were confined to the 12

13 Clinical Research Facility at least 10 hours prior to drug administration and until after the 30.0-hour post-dose blood draw. The treatment phases were separated by a washout period of 7 days. A total of 40 healthy volunteers were enrolled of which 39 completed the study. Randomisation Volunteers were randomised to one of the possible sequences and the randomisation was balanced for sequence. Administration of study medication A single 100 mg dose of test and reference products was administered with 240 ml of water. Subjects were dosed after an overnight fast which was consistent with the SPC (no effect of food seen). Washout period The washout period was 7 days which was adequate given that no volunteers had predose levels for period II. Sampling Samples were taken pre-dose and over 30 hours which was sufficient for adequate estimation of AUC for both losartan and its active metabolite. All blood samples were drawn into blood collection tubes (1 x 3 ml) containing EDTA K2 prior to drug administration and up to 30.0 hours post-dose. Dosing intervals are also considered suitable for the determination of Cmax (expected T max for losartan is 1 hour and 3-4 hours for its active metabolite). This was supported by the concentration-time curves for individual volunteers. Pre-specified bioequivalence acceptance range The protocol specified bioequivalence acceptance ranges of % for AUC which is acceptable. Statistical plan An adequate statistical plan was provided and the planned statistical methods were conventional. Log-transformed data for AUC (0-t), AUC (0-inf), and C max were analysed by ANOVA. T max was analysed using the Wilcoxon Signed-Rank test. Proposals for handling dropouts and other missing data Samples from 40 volunteers will be statistically analysed unless there are dropouts. Dropouts will not be replaced. Given the study numbers, this is acceptable. Study Outcome and Results Individual subject data The appearance and variability of the concentration-time curves for test and reference products were in line with expectations for the drug substance studied. The observed plasma half lives were consistent with published values (SPC, literature and expert report). 13

14 The measured AUC of losartan and its active metabolite was > 85% of the AUC extrapolated to infinity suggesting that the duration of sampling was adequate. Statistical analyses Calculated pharmacokinetic parameters are summarized in the following tables. Table 1: Ratio and 90% confidence intervals for losartan and losartan carboxy acid Study Parameter Ratio 1 (90% Confidence Interval 2 ) (%) Losartan Losartan carboxy acid AUC 0-t (ng h/ml) ( ) ( ) AUC- inf (ng h/ml) ( ) ( ) Cmax (ng/ml) ( ) ( ) 1 (Losartan Potassium (A) - Lorzaar Protect Calculated using least-squares means according to the formula e (B)) X 100; 2 90% Geometric Confidence Interval using ln-transformed data. 90% geometric confidence intervals of the ratio of least-squares means of the test to reference product of ln-transformed AUC 0-t and AUC0 inf and Cmax were included within 80% to 125%. Assessor's Conclusion on Bioequivalence Bioequivalence of the test product to the reference formulation has been satisfactorily demonstrated in accordance with CHMP criteria. The multiple dose waiver criteria are met and hence this study is accepted as demonstrating bioequivalence for the other product strengths. CLINICAL EFFICACY & SAFETY STUDIES No new clinical efficacy and safety data have been provided and this acceptable for a generic product based on essential similarity with a reference product. EXPERT REPORTS The expert is medically qualified and the expert non-clinical and clinical reports were adequate. PRODUCT LITERATURE Reviewed in the Quality assessment report. 14

15 V. USER CONSULTATION The package leaflet has been evaluated via a user consultation study, in accordance with the requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC. The language used for the purpose of user testing the PIL was English. The results show that the package leaflet meets the criteria for readability, as set out in the Guideline on the readability of the label and package leaflet of medicinal products for human use. VI. OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT AND RECOMMENDATION QUALITY The important quality characteristics of Losartan Potassium 12.5mg, 25mg, 50mg & 100mg 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 an application of this type. EFFICACY Bioequivalence has been demonstrated between the applicant s Losartan potassium 100mg film-coated tablets and the originator product Lorzaar Protect 100 mg (marketed in Germany, manufactured in UK by Merck Sharp Dohme Ltd.). Given that linear kinetics apply between the 100mg and 50mg, 25mg and 12.5mg tablets, that proportional formulae for the tablets have been used and that similar dissolution results have been shown for the four strengths; separate bioequivalence studies for the other strength tablets is not considered necessary. PRODUCT LITERATURE The approved SPCs, PIL and labelling are satisfactory. BENEFIT-RISK ASSESSMENT The quality of the product is acceptable and no new non-clinical or clinical safety concerns have been identified. Extensive clinical experience with Losartan is considered to have demonstrated the therapeutic value of the compound. The data provided in support of this application are acceptable. The risk: benefit is, therefore, considered to be positive. 15

16 LOSARTAN POTASSIUM 12.5, 25MG, 50MG & 100MG FILM- COATED TABLETS PL 14017/ STEPS TAKEN FOR ASSESMENT 1 The MHRA received the marketing authorisation application on 15 th September Following standard checks and communication with the applicant the MHRA considered the application valid on 9 th January Following assessment of the application the MHRA requested further information relating to the quality dossier on 12 th March The applicant responded to the MHRA s request, providing further information for the quality sections of the dossier on 26 December Following assessment of the application the MHRA requested further information relating to the quality dossier on 2 nd April The applicant responded to the MHRA s request, providing further information for the quality sections of the dossier on 5 th August Following assessment of the application the MHRA requested further information relating to the quality dossier on 15 th January The applicant responded to the MHRA s request, providing further information for the quality sections of the dossier on 7 th April The application was determined on 19 th June

17 Summary of Product Characteristics In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPCs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 17

18 Product Information Leaflets In accordance with Directive 2010/84/EU, the Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 18

19 LABELLING Losartan Potassium 12.5mg film-coated tablets- Carton Blister foil 19

20 Losartan Potassium 25mg film-coated tablets- Carton Blister foil 20

21 Losartan Potassium 50mg film-coated tablets- Carton Blister foil 21

22 Losartan Potassium 100mg film-coated tablets- Carton Blister foil 22

23 LOSARTAN POTASSIUM 12.5, 25MG, 50MG & 100MG FILM-COATED TABLETS PL 14017/ STEPS TAKEN AFTER AUTHORISATION-SUMMARY The following table lists non-safety updates to the Marketing Authorisations (PL 14017/ ) for these products that have been approved by the MHRA since the products were first licensed. The table includes updates that have been added as an annex to this PAR. This is not a complete list of the post-authorisation changes that have been made to these Marketing Authorisations. Date submitted Application type Scope Outcome 16 March 2014 Type 1B To update section 4.2, 4.6 and 5.1 of the Summary of Product Characteristics (SmPC) in line with the reference product Cozaar 12.5mg, 25mg, 50mg and 100mg Film-Coated Tablets. As a consequence, the Patient Information Leaflet (PIL) has been updated. Minor amendments have also been made to the labelling (to depict the embossing position of batch expiry on the blister mockups). Approved 31 March

24 ANNEX 1 Our Reference: PL 14017/ PL 14017/ PL 14017/ PL 14017/ Product: Marketing Authorisation Holder: Active Ingredient(s): Losartan potassium 12.5 mg film-coated tablets Losartan potassium 25 mg film-coated tablets Losartan potassium 50 mg film-coated tablets Losartan potassium 100 mg film-coated tablets Dexcel Pharma Limited Losartan potassium. Type of Procedure: Submission Type: Submission Category: Submission Complexity: EU Procedure Number (if applicable): National Variation Type IB Standard Not applicable Reason: To update section 4.2, 4.6 and 5.1 of the Summary of Product Characteristics (SmPC) in line with the reference product Cozaar 12.5mg, 25mg, 50mg and 100mg Film- Coated Tablets. As a consequence, the Patient Information Leaflet (PIL) has been updated. Minor amendments have also been made to the labelling (to depict the embossing position of batch expiry on the blister mock-ups). Supporting Evidence Revised SmPC fragments, PIL and labelling. Evaluation The proposed changes to the SmPCs, and PIL are in line with the reference product. The updated SmPC fragments, PIL and labelling have been incorporated into the Marketing Authorisations: 24

25 25

26 26

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31 31

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40 40

41 Conclusion The proposed changes to the SmPCs, PIL and labelling are acceptable. Decision - Approved on 31 March

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