Public Assessment Report. Scientific discussion. Levodopa/Carbidopa/Entacapone Teva B.V.
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1 Public Assessment Report Scientific discussion Levodopa/Carbidopa/Entacapone Teva B.V. 50 mg/12.5 mg/200 mg 75 mg/18.75 mg/200 mg 100 mg/25 mg/200 mg 125 mg/31.25 mg/200 mg 150 mg/37.5 mg/200 mg 175 mg/43.75 mg/200 mg 200 mg/50 mg/200 mg Film-coated tablets (Levodopa/Carbidopa/Entacapone) DK/H/2350/ /DC 21 June 2016 This module reflects the scientific discussion for the approval of Levodopa/Carbidopa/Entacapone Teva B.V.. The procedure was finalised on 7 August For information on changes after this date please refer to the module Update.
2 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Levodopa/Carbidopa/Entacapone Teva B.V. 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, 150 mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg and 200 mg/50 mg/200 mg film-coated tablets, from Teva B.V. The product is indicated for the treatment of adult patients with Parkinson s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment. A comprehensive description of the indications and posology is given in the SmPC. According to the current understanding, the symptoms of Parkinson s disease are related to depletion of dopamine in the corpus striatum. Dopamine does not cross the blood-brain barrier. Levodopa, the precursor of dopamine, crosses the blood brain barrier and relieves the symptoms of the disease. As levodopa is extensively metabolised in the periphery, only a small portion of a given dose reaches the central nervous system when levodopa is administered without metabolic enzyme inhibitors. Carbidopa and benserazide are peripheral DDC inhibitors which reduce the peripheral metabolism of levodopa to dopamine, and thus, more levodopa is available to the brain. When decarboxylation of levodopa is reduced with the co-administration of a DDC inhibitor, a lower dose of levodopa can be used and the incidence of adverse reactions such as nausea is reduced. With inhibition of the decarboxylase by a DDC inhibitor, catechol-o-methyltransferase (COMT) becomes the major peripheral metabolic pathway catalyzing the conversion of levodopa to 3- Omethyldopa (3-OMD), a potentially harmful metabolite of levodopa. Entacapone is a reversible, specific and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa. Entacapone slows the clearance of levodopa from the bloodstream resulting in an increased area under the curve (AUC) in the pharmacokinetic profile of levodopa. Consequently the clinical response to each dose of levodopa is enhanced and prolonged. This decentralised procedure concerns a generic application claiming essential similarity with the reference product Stalevo which has been registered in Europe by Orion Corporation since The marketing authorisation is granted based on article 10(1) of Directive 2001/83/EC. II. QUALITY ASPECTS II.1 Introduction The pharmaceutical form is film-coated tablets and the strength and appearance of the tablets are as follows: 50 mg/12.5 mg/200 mg: Round, biconvex, light brown tablet, marked with 50 on one side, plain on the other. Dimensions: approx. 14 mm diameter. 75 mg/18.75 mg/200 mg: Oval, biconvex, light orange tablet, marked with 75 on one side, plain on the other. Dimensions: approx. 16x10 mm. 100 mg/25 mg mg/200 mg: Oblong, biconvex, pale red tablet, marked with 100 on one side, plain on the other. Dimensions: approx. 17x9 mm. 2/14
3 125 mg/31.25 mg/200 mg: Round, biconvex, yellowish brown tablet, marked with 125 on one side, plain on the other. Dimensions: approx. 14 mm diameter. 150 mg/37.5 mg/200 mg: Oval, biconvex, dark red tablet, marked with 150 on one side, plain on the other. Dimensions: approx. 16x10 mm. 175 mg/43.75 mg/200 mg: Ellipse, biconvex, pale brown tablet, marked with 175 on one side, plain on the other. Dimensions: approx. 17x10 mm 200 mg/50 mg/200 mg: Oblong, biconvex, brown tablet, marked with 200 on one side, plain on the other. Dimensions: approx. 17x9 mm. The product is supplied in white opaque HDPE tablet containers with white opaque PP tamper evident (TE) or tamper-evident/senior friendly (TE/SF) or tamper evident/child resistant/senior friendly (TE/CR/SF) screw cap with desiccant insert in pack-sizes of: 10, 28, 30, 50, 60, 90, 98, 100, 130, 150, 175, 200 and 250 film-coated tablets. However, not all pack sizes may be marketed. The tablet core contains: Microcrystalline cellulose; Lactose anhydrous; Hydroxypropylcellulose; Povidone (K-30); Silica, colloidal anhydrous and Magnesium stearate. The film-coating consists of: 50 mg/12.5 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171), Hypromellose Glycerol (E422) Iron oxide yellow (E172) Polysorbate 80 Iron oxide red (E172) Iron oxide black (E172) Magnesium stearate 75 mg/18.75 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) Hypromellos Glycerol (E422) Iron oxide yellow (E172) Polysorbate 80 Iron oxide red (E172) Magnesium stearate 100 mg/25 mg mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) Hypromellose Glycerol (E422) Polysorbate 80 Allura red ac (E129) Carmine (E120) Magnesium stearate 125 mg/31.25 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) Hypromellose, Glycerol (E422) Iron oxide yellow (E172) Polysorbate 80 Iron oxide red (E172) Magnesium stearate 150 mg/37.5 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) 3/14
4 Hypromellose Glycerol (E422) Polysorbate 80 Iron oxide red (E172) Carmoisine (E122) Magnesium stearate 175 mg/43.75 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) Hypromellose Glycerol (E422) yellow iron oxide (E172) Polysorbate 80 Iron oxide red (E172) Iron oxide black (E172) Magnesium stearate 200 mg/50 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) Hypromellose Glycerol (E422) Iron oxide yellow (E172) Polysorbate 80 Iron oxide red (E172) Iron oxide black (E172) Magnesium stearate The RMS has been assured that acceptable standards of GMP (see Directive 2003/94/EC) are in place for this product type at all sites responsible for the manufacturing of the active substance as well as for the manufacturing and assembly of this product prior to granting its national authorisation. II.2 Drug Substance The finished product contains 3 drug substances: Levadopa, carbidopa and entacapone. The documentation on the drug substance levadopa is covered by a CEP. Levodopa is described in the European Pharmacopoeia, and in-house specifications have been established. A compiled specification is presented. Based on the presented stability studies, an appropriate re-test period has been set. The documentation on the drug substance carbidopa is covered by a CEP. The applicant specification has been provided and is found acceptable. The drug substance entacapone is covered by a CEP. The applicant specification has been provided and is found acceptable. II.3 Medicinal Product The product is film-coated tablets and is available in 7 strengths. All strengths contain 200 mg entacapone and proportional content of levodopa and carbidopa with a ratio of 4:1. The pharmaceutical development work is described in detail. The formulation is chosen in order to resemble the reference product with regard to content of active substance, but the other excipients and mass of tablets differ. The development was based on bioequivalence studies; the reference product and 4/14
5 applied products have different dissolution profiles but are similar with respect to bioequivalence. The discriminating power of the dissolution method was demonstrated, the development of the manufacturing process described and explanation for selection of the final formulation given. The impurity profile of the applied product and reference product are compared and found to be almost similar with respect to the specified impurities. The manufacturing process has been described and justified by validation. Bulk storage period is applied and stability data are provided. The bulk storage period is accepted. The product specification covers appropriate parameters for this dosage form and is found acceptable. Acceptable validations of the analytical methods have been presented. Batch analysis has been performed on 2-3 pilot scale batches of each strength. The batch analysis results show that the finished products meet the specifications. The proposed shelf-life of the unopened product of 2 years with no special storage conditions is acceptable. Data for in-use stability and photostability have been presented. III. NON-CLINICAL ASPECTS III.1 Introduction Pharmacodynamic, pharmacokinetic and toxicological properties of levodopa, carbidopa and entacapone are well known. As levodopa, carbidopa and entacapone are widely used well-known active substances, the MAH has not provided additional studies and further studies are not required. Overview based on literature review is, thus, appropriate. The non-clinical overview report refers numerous publications up to year The non-clinical overview on the pre-clinical pharmacology, pharmacokinetics and toxicology is adequate. III.2 Ecotoxicity/environmental risk assessment (ERA) The product is intended as a substitute for other identical products on the market. The approval of this product will not result in an increase in the total quantity of levodopa, carbidopa and entacapone released into the environment. It does not contain any component, which results in an additional hazard to the environment during storage, distribution, use and disposal. IV. CLINICAL ASPECTS IV.1 Introduction Levodopa, carbidopa and entacapone are well-known active substances with established efficacy and tolerability. As Levodopa, carbidopa and entacapone are widely used, well-known active substances, the MAH has not provided additional studies (apart from supportive bioequivalence studies referenced below) and further studies are not required. Overview based on literature review is, thus, appropriate. The clinical overview report refers numerous publications up to year 2013.The clinical overview on the clinical pharmacology, efficacy and safety is adequate. 5/14
6 Biowaiver Levodopa/Carbidopa/Entacapone Teva B.V. film-coated tablets are presented in seven strength combinations. The bioequivalence studies were carried out with the lowest and highest strengths applied for i.e. 50 mg/12.5 mg/200 mg and 200 mg/50 mg/200 mg. A waiver of bioequivalence studies with the additional strengths was applied for and was adequately justified. Bioequivalence study To support the application, the MAH has submitted as report 2 pivotal and 2 pilot bioequivalence studies. Pivotal bioequivalence studies: - 50 mg/12.5 mg/200 mg, fully replicated crossover study under fasting conditions mg/50 mg/200 mg, fully replicated crossover study under fasting conditions. Pilot studies: - 50 mg/12.5 mg/200 mg, single-dose, four period, four treatment crossover study under fasting conditions to evaluate BE between three test formulations and the reference product mg/50 mg/200 mg, single-dose, four period, four treatment crossover study under fasting conditions to evaluate BE between three test formulations and the reference product. The two pilot studies aimed to select the optimal formulation of the fixed combination product. For the pilot studies only the study synopsis is presented. Pivotal studies The pivotal bioequivalence studies were open-label, randomized, two-treatment, four-sequence, four period, four-way replicated crossover, single-dose bioavailability studies conducted under fasting conditions with a wash out period of 7 days between the administrations. 50 mg/12.5 mg/200 mg study The study was an open-label, randomized, two-treatment, four-sequence, four-period, four-way replicated crossover, single-dose bioavailability study conducted under fasting conditions with a wash out period of 7 days between the administrations. One film-coated tablet of 50/12.5/200 mg of either the test product Levodopa/Carbidopa/Entacapone Teva B.V. or the reference product Stalevo film-coated tablets, Orion Corporation, from the German market was administered in each period. 70 healthy subjects participated in the study. 61 subjects completed all 4 periods of the study. In accordance with the study protocol, data from all subjects who completed at least 2 periods, including one test and one reference, and for whom the PK profile was adequately characterized were used for PK and statistical analyses (N=68). For levodopa, the PK population included the first 20 subjects of each main group (20/30 and 20/40) completing the first 2 periods, and for whom the PK profile could be adequately characterised. Pharmacokinetic population: N=40 for Levodopa N=68 for Carbidopa N=68 for Entacapone Primary variables were AUC 0-t and C max. Criteria for bioequivalence for levodopa: 90% geometric confidence intervals of the ratio (A/B) of least-squares means from the ANOVA of the ln-transformed AUC 0-t and C max should be within 80.00% to %. Criteria for bioequivalence for carbidopa and entacapone: The 90% geometric confidence intervals of the ratio (A/B) of LS means of the ln-transformed AUC 0-t should be within 80.00% to %; If the within-subject coefficient of variation of the reference product (CVWR) is 30% for C max, then the 90% geometric confidence intervals of the ratio (A/B) of LS means of the lntransformed C max should be within 80.00% to %. Otherwise, if the CVWR is > 30% for C max, a scaled-average bioequivalence criterion should be 6/14
7 Results Levodopa used for this parameter. The test-to-reference geometric mean ratio (A/B) should lie within the conventional acceptance range of %. The acceptance criteria for the 90% geometric confidence intervals of the ratio (A/B) of LS means for C max could be widened based upon the reference within-subject variability to a maximum of %. Table 1. Summary of pharmacokinetic parameters for levodopa for each treatment Table 2. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for levodopa 7/14
8 Carbidopa Table 3. Summary of pharmacokinetic parameters for carbidopa for each treatment Table 4. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for carbidopa 8/14
9 Table 5. Summary of pharmacokinetic parameters for entacapone for each treatment Table 6. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for entacapone For all three analytes levodopa, carbidopa and entacapone the 90% confidence interval was within the conventional acceptance limits of %; therefore, although the CV% for C max for entacapone was >30%, no scaling for widening of the acceptance limits as considered in the protocol was performed. 200 mg/50 mg/200 mg study The study was an open-label, randomized, four-treatment, two-sequence, four-period, four-way replicated crossover, single-dose bioavailability study conducted under fasting conditions with a wash out period of 7 days between the administrations. One film-coated tablet of 200/50/200 mg of either the test product Levodopa/Carbidopa/Entacapone Teva B.V. or the reference product Stalevo film-coated tablets, Orion Corporation, from the German market was administered in each period. 60 healthy subjects participated in the study. 35 subjects completed all 4 periods of the study. Pharmacokinetic population: N=20 for Levodopa N=45 for Carbidopa N=55 for Entacapone 9/14
10 Primary variables were AUC 0-t and C max. Criteria for bioequivalence levodopa: 90% geometric confidence intervals of the ratio (A/B) of least-squares means from the ANOVA of the ln-transformed AUC 0-t and C max should be within 80.00% to %. Criteria for bioequivalence for carbidopa and entacapone: The 90% geometric confidence intervals of the ratio (A/B) of LS means of the ln-transformed AUC 0-t should be within 80.00% to %; If the within-subject coefficient of variation of the reference product (CVWR) is 30% for C max, then the 90% geometric confidence intervals of the ratio (A/B) of LS means of the lntransformed C max should be within 80.00% to %. Otherwise, if the CVWR is > 30% for C max, a scaled-average bioequivalence criterion should be used for this parameter. The test-to-reference geometric mean ratio (A/B) should lie within the conventional acceptance range of %. The acceptance criteria for the 90% geometric confidence intervals of the ratio (A/B) of LS means for C max could be widened based upon the reference within-subject variability to a maximum of %. Results Levodopa Table 7. Summary of pharmacokinetic parameters for levodopa for each treatment Table 8. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for levodopa 10/14
11 Carbidopa Table 9. Summary of pharmacokinetic parameters for carbidopa for each treatment Table 10. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for carbidopa 11/14
12 Table 11. Summary of pharmacokinetic parameters for entacapone for each treatment Table 12. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for entacapone 12/14
13 For all three analytes levodopa, carbidopa and entacapone the 90% confidence interval was within the conventional acceptance limits of %; therefore, although the CV% for C max for entacapone was >30% no scaling was performed. Pharmacokinetic conclusion Based on the submitted bioequivalence studies Levodopa/Carbidopa/Entacapone Teva B.V. 50/12.5/200 mg and 200/50/200 mg film-coated tablets are considered bioequivalent with Stalevo 50/12.5/200 mg and 200/50/200 mg film-coated tablets. The results of the study with 200 mg/50 mg/ 200 mg formulation and 50 mg/12.5 mg/200 mg formulation can be extrapolated to the other strengths 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, 150 mg/37.25 mg/200 mg and 175 mg/43.75 mg/200 mg, according to conditions in Guideline on the Investigation of Bioequivalence CPMP/EWP/QWP/1401/98 Rev. 1/Corr*, section The RMS has been assured that the bioequivalence study has been conducted in accordance with acceptable standards of Good Clinical Practice (GCP, see Directive 2005/28/EC) and Good Laboratory Practice (GLP, see Directives 2004/9/EC and 2004/10/EC). IV.2 Risk Management Plan The MAH has submitted a risk management plan, in accordance with the requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to Levodopa/Carbidopa/Entacapone Teva B.V.. The following summary list of safety concerns has been agreed with no additional pharmacovigilance or risk minimisation measures: Table 1: Summary table of safety concerns as approved in RMP 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. 13/14
14 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. The test consisted of a pilot test with 2 participants, followed by two rounds with 10 participants each. The questions covered the following areas sufficiently: traceability, comprehensibility and applicability. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Levodopa/Carbidopa/Entacapone Teva B.V. film-coated tablets has a proven chemicalpharmaceutical quality and is comparable to Stalevo. Stalevo is a well-known medicinal product with an established favourable efficacy and safety profile. Bioequivalence has been shown to be in compliance with the requirements of European guidance documents. Agreement between Member States was reached during a written procedure. There was no discussion in the CMD(h). The Concerned Member States, on the basis of the data submitted, considered that a marketing authorisation for Levodopa/Carbidopa/Entacapone Teva B.V. could be granted. The decentralised procedure was finalised on 7 August Levodopa/Carbidopa/Entacapone Teva B.V. was authorised in Denmark on 8 October According to the List of Union reference dates and frequency of submission of periodic safety update reports (PSURs), no routine PSURs are required for this product. The date for the first renewal will be: 17 October There were no post-approval commitments made during the procedure. 14/14
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