Public Assessment Report. Scientific discussion. Atorvastatin Germania 10/20/40 mg Filmtabletten Atorvastatin calcium, trihydrate AT/H/0461/01-03/DC

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1 Public Assessment Report Scientific discussion Atorvastatin Germania 10/20/40 mg Filmtabletten Atorvastatin calcium, trihydrate AT/H/0461/01-03/DC This module reflects the scientific discussion for the approval of Atorvastatin Germania 10/20/40 mg Filmtabletten. The procedure was finalised on /6

2 I. INTRODUCTION Based on the review of the data and the Applicant s response to the questions raised by RMS and CMSs on quality, safety and efficacy, the RMS considers that the application Atorvastatin Germania 10/20/40 mg Filmtabletten in the treatment of primary hyperlipidemia and prevention of cardiovascular disease (for exact wording of indications, see SmPC) is approvable. II. II.1 EXECUTIVE SUMMARY Problem statement This application through the Decentralised Procedure concerns Atorvastatin 10, 20 and 40 mg filmcoated tablets. These tablets are a generic version of Sortis marketed by Pfizer/Parke Davis. The originator product was approved in the United Kingdom in 1996, as Lipitor (=Sortis) in its 40mg strength. Note: In this Assessment Report, the name Sortis is used. Through an MR-procedure, Sortis 10, 20 and 40mg tablets were authorized across the EU in 1997, Sortis 80mg followed in 2002 (DE/H/109/01-04), involving AT, BE, DE, DK, FI, EL, IT, LU, NL, PT, ES and SE as CMS and DE acting as RMS. Licensed trade names are: Sortis, Lipitor, Zarator, Liprimar, Xarator, Cardyl and Tahor (Pfizer/Parke-Davis). With Austria as Reference Member State in this Decentralised Procedure, Pharmavision GmbH is applying for Marketing Authorisation of following products in the following listed countries: DE. II.2 About the product Atorvastatin is a synthetic HMG-CoA reductase inhibitor (Statin). Statins revolutionized treatment of hypercholesterolemia as other lipid lowering agents were either modest in respect of efficacy or unacceptable in terms of side effects. Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols including cholesterol. It also reduces triglyceride levels through an as yet unproven mechanism. Atorvastatin reduces levels of cholesterol and lipoproteins in plasma by inhibiting of HMG-CoA reductase and by inhibiting of cholesterol synthesis in liver, and it increases a number of hepatic LDL receptors on the cellular surface, accelerating thus the absorption and catabolism of LDL. Atorvastatin reduces the production of LDL and a number of LDL particles. It also decreases effectively LDL-cholesterol levels in patients with homozygous familial hypercholesterolemia, which is the population of patients usually not reacting to hypolipidemic treatment. It has been demonstrated that reduction of total cholesterol, LDL-cholesterol and triglycerides decreases the risk of cardiovascular episodes and cardiovascular mortality. Studies following an influence of atorvastatin on mortality and morbidity have not been established yet. Currently approved indications: Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides in patients with primary hypercholesterolemia (including heterozygous, familial hypercholesterolemia) or mixed hyperlipidaemia (Fredrickson 2/6

3 classification, Types IIa and IIb), when response to diet and other nonpharmacological measures is inadequate. Atorvastatin is also indicated to reduce total- or LDL-cholesterol in patients suffering from homozygous familial hypercholesterolemia, either combined with other blood fat lowering actions (e.g. aphaeresis) or if such treatments are unavailable. Furthermore, Atorvastatin is indicated for the prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see Section 5.1), as an adjunct to correction of other risk factors. Currently approved doses include 10, 20, 40 and 80mg once daily, taken at any time of the day independent from concomitant intake of meals. The initial daily dosage is 10mg and is to be adjusted at intervals of 4 weeks and more up to a maximum daily dose of 80mg. II.3 General comments on the submitted dossier This application of marketing authorisation on Atorvastatin is based on Article 10(1) generic application. The originator product on the Austrian market is Sortis 10/20/40/80mg (Pfizer/Parke Davis). In order to prove essential similarity to the originator product a bioequivalence study with the 40mg strength has been performed against the originator product from the German market (Sortis 40 mg Tablets, manufactured by Pfizer Pharma GmbH, Berlin). A biowaiver-justification to extrapolate the results from the BE-study to the 10 and 20 mg strengths has been provided. II.4 General comments on compliance with GMP, GLP, GCP and agreed ethical principles. The RMS has been assured that acceptable standards of GMP are in place for these product types at all sites responsible for the manufacture and assembly of this product. 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. The applicant assures that the submitted bioequivalence study has been conducted according GCPand GLP-standards. III. III.1 QUALITY ASPECTS Introduction Atorvastatin Germania is a film-coated tablet which is presented in an Aluminium/Aluminium blister. III.2 Drug Substance 3/6

4 The active substance in Atorvastatin Germania is Atorvastatin (as Atorvastatin calcium trihydrate). The specification of the active substance meets the current scientific requirements. The adequate quality of the active substance has been shown by submitting the appropriate control data. The stability of the active substance has been tested under ICH conditions. The results of the stability studies support the established retest-period. III.3 Medicinal Product Atorvastatin Germania contains the following excipients: Atorvastatin Germania 10 mg Filmtabletten: Cellulose (microcrystalline), lactose monohydrate (34,42 mg), calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, water (purified), magnesium stearate, carnauba wax, hypromellose, titanium dioxide, macrogol, disodium edetate, iron oxide black. Atorvastatin Germania 20 mg Filmtabletten: Cellulose (microcrystalline), lactose monohydrate (68,84 mg), calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, water (purified), magnesium stearate, carnauba wax, hypromellose, titanium dioxide, macrogol, triacetin, brilliant blue FCF aluminium lake, indigo carmine aluminium lake, quinoline yellow aluminium lake. Atorvastatin Germania 40 mg Filmtabletten: Cellulose (microcrystalline), lactose monohydrate (137,68 mg), calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, water (purified), magnesium stearate, carnauba wax, hypromellose, titanium dioxide, macrogol, disodium edetate, iron oxide black. The manufacturers responsible for batch release are ADL Pharma GmbH, DE and Pharmavision GmbH, AT. The development of the product has been sufficiently made and deemed appropriate. The usage of all the excipients has been described. The release specification includes the check of all parameters relevant to this pharmaceutical form. Appropriate data concerning the control of the finished product support the compliance with the release specifications. The packaging of the medicinal product complies with the current legal requirements. Stability studies under ICH conditions have been performed and data presented support the shelf life claimed in the SmPC, with a shelf life of 24 months. The pharmaceutical quality of Atorvastatin Germania has been adequately shown. III.4 Discussion on chemical, pharmaceutical and biological aspects Information on development, manufacture and control of active substance and medicinal product has been presented in a satisfactory manner. The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics. IV. NON-CLINICAL ASPECTS Pharmacodynamic, pharmacokinetic and toxicological properties of atorvastatin are well known. As 4/6

5 atorvastatin is a widely used, well-known active substance, further studies were not required and the applicant provides none. Environmental Risk Assessment (ERA) This product is intended to substitute for other identical products on the market. The approval of this product does not result in an increase of the total quantity of atorvastatin released into the environment. It does not contain any component which would result in an additional hazard to the environment during storage, distribution, use and disposal. V. CLINICAL ASPECTS Pharmacokinetics Absorption: Atorvastatin is rapidly absorbed after oral administration, maximum plasma concentrations (C max) occur within 1 to 2 hours. The low absolute bioavailability of atorvastatin parent drug of approximately 12% -14% is due to presystemic clearance in the gastrointestinal mucosa and/or firstpass metabolism in the liver, its primary site of action. The systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%. Although food decreases rate and extent (C max, AUC) of drug absorption by approximately 25% and 9% respectively, LDL-C reduction is similar whether atorvastatin is given with or without food. Following evening drug administration atorvastatin plasma concentrations are 30% lower for C max and AUC when compared with morning drug administration. However, LDL-C reduction is the same regardless of the time of day of administration. Extent of absorption increases in proportion to atorvastatin dose. Dose dependent reductions in LDL cholesterol levels ranging from 41% to 61% have been reported for the dose range of 10 to 80 mg/dl. Grapefruit juice in large amounts has been shown to interfere with the metabolism of atorvastatin, causing increases in C max and AUC. Distribution: Mean volume of distribution is approximately 381 litres. Protein binding is very high (> 98%). Metabolism: Atorvastatin undergoes extensive hepatic and/or extra-hepatic metabolism. Atorvastatin is metabolized by cytochrome P450 3A4 to ortho (= 2-OH)- and para-(= 4-OH)hydroxylated derivates and various beta-oxidation products. Atorvastatin and its 2-OH- and 4-OH- metabolites were found to have equal inhibitory effects on HMG-CoA reductase in vitro. The active metabolites are responsible for approximately 70% of the inhibition of HMG-CoA reductase. Atorvastatin is extensively metabolized in the gut wall and liver, at least in part by the CYP3A4 enzymes. The 2-OH- and 4-OH-atorvastatin metabolites have HMG-CoA reductase inhibitory activity equal to that of Atorvastatin. Approximately 70% of atorvastatin s pharmacological activity is attributed to active metabolites. However, the 4-OH-metabolite has much lower concentrations and may not contribute significantly to the drug activity. Therefore, additional to the plasma concentrations of atorvastatin, concentrations of the active metabolite ortho-hydroxyatorvastatin (2-OH-Atorvastatin) were measured. Excretion: Following hepatic/extrahepatic metabolism, atorvastatin is primarily eliminated in bile although atorvastatin doesn t show significant enterohepatic recirculation. 5/6

6 Elimination half-life is approximately 14 hours however due to the contribution of active metabolites the inhibitory activity for HMG-CoA reductase is approximately hours. Bioequivalence Study The bioequivalence study was carried out at Fortis Clinical Research Limited, Haryana, India (2012). The objective of this study was to assess bioequivalence of the test formulation Atova 40mg (Atorvastatin 40 mg Pharmavision GmbH) in comparison to the reference formulation Sortis 40 mg Filmtabletten (Atorvastatin Pfizer Pharma GmbH Berlin). Therefore an open label, balanced, randomised, two-treatment, three-period, three-sequence, single-dose, crossover design in 57 adult, healthy male subjects (18-45 years) under fasting conditions was chosen. There were two drop-outs (No.55 for personal reasons, No.20 due to an intercurrent illness), resulting in 55 subjects completing the study. Bioequivalence was determined based on the 90% confidence interval for the ratio of the test and reference product averages (geometric least square means) of the pharmacokinetic parameters Cmax and AUCo-t; these should be between 80% and 125% for the log-transformed data. For both, parent drug (atorvastatin) and metabolites (ortho-hydroxy Atorvastatin and para-hydroxy Atorvastatin) the 90% confidence intervals of the mean ratio of ln-transformed C max, AUC t and AUCinf were within the % acceptance range. Based on these results Atova 40mg (Atorvastatin 40 mg Pharmavision GmbH) can be considered bioequivalent with Sortis 40 mg Filmtabletten (Atorvastatin 40mg Pfizer Pharma GmbH Berlin). Regarding safety, no serious adverse events occurred during the conduct of the bioequivalence study. The applicant requested a biowaiver for the 10 and 20mg strengths. All conditions for the biowaiver were met. Thus, data from the 40 mg BE study can be extrapolated to the lower strengths, as the requirements of the guideline are fulfilled. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Based on the results of the submitted bioequivalence study which was performed with the 40mg strength, the Test and the Reference product can be regarded as bioequivalent. The submitted biowaiver meets the requirements of the Guideline on the Investigation of Bioequivalence (Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **, 2010). Hence the results of the BE-study can also be extrapolated to the 10mg and 20mg strengths. Therefore from a non-/clinical point of view, Atorvastatin Germania 10/20/40 mg (Pharmavision GmbH) is approvable. User consultation The submitted User-Test is acceptable 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 German. 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. 6/6

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