Public Assessment Report. Scientific discussion. Imipenem/Cilastatine Stravencon 250 mg/250 mg and 500 mg/500 mg powder for solution for infusion

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1 Public Assessment Report Scientific discussion Imipenem/Cilastatine Stravencon 250 mg/250 mg and 500 mg/500 mg powder for solution for infusion (imipenem monohydrate/cilastatin sodium) NL/H/3075/ /DC Date: 12 March 2015 This module reflects the scientific discussion for the approval of Imipenem/Cilastatine Stravencon 250 mg/250 mg and 500 mg/500 mg powder for solution for infusion. The procedure was finalised on 30 October 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 Imipenem/Cilastatine Stravencon 250 mg/250 mg and 500 mg/500 mg powder for solution for infusion from Stravencon Limited. The product is indicated for in adults and children 1 year of age and above for: complicated intra-abdominal infections severe pneumonia including hospital and ventilator-associated pneumonia intra- and post-partum infections complicated urinary tract infections complicated skin and soft-tissue infections Imipenem/Cilastatin Stravencon may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. A comprehensive description of the indications and posology is given in the SmPC. Imipenem is an intravenous β-lactam antibiotic. Cilastatin inhibits the human enzyme dehydropeptidase found in the kidney and is responsible for degrading the antibiotic imipenem. Cilastatin can therefore be combined intravenously with imipenem in order to protect it from dehydropeptidase and prolong its antibacterial effect. Cilastatin itself does not have antibiotic activity. This decentralised procedure concerns a generic application claiming essential similarity with the innovator product Tienam, powder for solution for infusion 500 mg/500 mg (NL License RVG 11089) which has been registered in the Netherlands by Merck Sharp & Dohme B.V. since 1986 (original product). The concerned member states (CMS) involved in this procedure were: For 250 mg/250 mg and 500 mg/500 mg: Austria, Germany and Spain. For 500 mg/500 mg: Finland, Poland, Sweden and the United Kingdom The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC for the 500 mg/500 mg strength. For the 250 mg/250 mg strength the applicable legal base is Article 10(3), hybrid application, since this strength is not authorised. II. QUALITY ASPECTS II.1 Introduction Imipenem/Cilastatine Stravencon is a white to light yellow powder. The reconstituted solution is clear, with ph between 6.5 and 8.5 The powder for solution for infusion is packed in 20 ml Type I colorless glass vials with chlorobutyl rubber stoppers and flip-off aluminium seals. Each vial contains imipenem monohydrate equivalent to 250 mg imipenem anhydrate and cilastatin sodium equivalent to 250 mg cilastatin base, or imipenem monohydrate equivalent to 500 mg imipenem anhydrate and cilastatin sodium equivalent to 500 mg cilastatin base. The only excipient present in the drug product is sodium hydrogen carbonate. 2/8

3 II.2 Drug Substances C Imipenem monohydrate The active substance imipenem monohydrate is an established active substance described in the European Pharmacopoeia (Ph.Eur.). The active substance is sparingly soluble in water and slightly soluble in methanol sparingly soluble in the ph range of 6.5 to 8.5. Two characteristic crystal XRD patterns are observed (Form I and Form II). Results show that the manufactured form is identical to Form I. There are three chiral centres within the structure of the active substance. The Active Substance Master File (ASMF) procedure is used for imipenem. The main objective of the ASMF procedure, commonly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or know-how of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the applicant or marketing authorisation holder (MAH) to take full responsibility for the medicinal product, the quality and quality control of the active substance. Competent Authorities/EMA thus have access to the complete information that is necessary to evaluate the suitability of the use of the active substance in the medicinal product.> Manufacturing process The manufacturing process consist of 8 steps followed by 3 purification steps. The structure of the active substance has been adequately elucidated. The impurities including potential genotoxic impurities have been discussed. No class I residual solvents are used in the manufacturing process. Quality control of drug substance The drug substance specification is in line with the Ph.Eur., with additional requirements for residual solvents. The specification is acceptable. Batch analytical data demonstrating compliance with the drug substance specification have been provided for 3 full-scale batches. Stability of drug substance Stability data on the active substance have been provided for 3 full-scale batches stored at fill in 5 C (36 months) and 25 C/60% RH (6 months). At accelerated and long term conditions no obvious trends were observed. Based on the data provided, the claimed retest period of 36 months when stored at 2-8 C is acceptable. Cilastatin sodium The second active substance, cilastatin sodium, is an established active substance described in the Ph.Eur. The active substance is very soluble in water and methanol, practically insoluble in acetone and methylene chloride. Cilastatin contains 2 chiral centres. There is no possibility of isomerisation for the manufactured product with current synthesis route. The ASMF-procedure is used. Manufacturing process The product is formed in a series of reaction steps. The active substance has been adequately characterized and acceptable specifications have been adopted for the starting material, solvents and reagents. Quality control of drug substance The drug substance specification is in line with the Ph.Eur. with additional requirements for particulate matter, residual solvents. The specification is acceptable. Batch analytical data demonstrating compliance with the drug substance specification have been provided for 3 full-scale batches. Stability of drug substance Stability data on the active substance have been provided for 3 full-scale batches stored at fill in 25 C/60% RH (6 months) and 25 C/60% RH (24 months up to 36 months). At accelerated and long term conditions a decrease as well as an increase in total impurities was observed. However, the results remained within the specifications. On the basis of the submitted data, the proposed re-test period of 36 months can be granted. The proposed storage condition of 2-8 C is acceptable; this is in accordance with the Ph.Eur. monograph on cilastatin sodium. II.3 Medicinal Product 3/8

4 Pharmaceutical development The development of the product has been described, the choice of excipients is justified and their functions explained. The aim of pharmaceutical development was to develop a drug product essentially similar to Tienam (MSD), which contains the same drug substances. The comparative test results demonstrated that the test and reference product are comparable. No significant differences were observed. Since the drug product is administered as aqueous solution for infusion containing the same active substances in the same concentration no bioequivalence study is required according to CPMP/EWP/QWP/1401/98 Note for guidance on the investigation of bioavailability and bioequivalence. The MAH demonstrated that sterilisation of the drug product by heat is not suitable. The choice of filtration and aseptic processing is justified. The pharmaceutical development of the product has been adequately performed. Manufacturing process The manufacturing process consists of blending of the sterile active substances and the excipient and aseptic filling of the vials under nitrogen. It is considered a non-standard process. The manufacturing process has been adequately validated according to relevant European guidelines. This process was validated on three consecutive full-scale batches. Validation data of the bulk sterile blend operations to obtain imipenem/cilastatin for injection, including media fill simulation and sterilization and equipment qualification, and for the filling and sealing operations to obtain the finished product are presented. The maximum batch size has been adequately validated and is acceptable. Control of excipients Nitrogen and sodium bicarbonate are in accordance with their Ph.Eur. monograph. These specifications are acceptable. Microbiological attributes Sufficient information has been provided on the sterilization and depyrogenation of the vials and sterilisation of the stoppers. The test for bacterial endotoxins and sterility is included in the drug product specification. Quality control of drug product The product specification includes tests for appearance, identity, appearance of solution, ph, loss on drying, reconstitution time, assay, uniformity of content, average weight, particulate contamination, bacterial endotoxins, sterility, content of sodium and related substances. The release and shelf-life requirements/limits are identical. The methods have been adequately validated. Batch analytical data from the proposed production site have been provided on 5 sterile bulk blend batches and 3 full-scale drug product batches per strength demonstrating compliance with the release specification. Stability of drug product Stability data on the product has been provided on 3 sterile bulk blend batches and 3 drug product batches per strength stored at 25 C/60% RH (24 months) and 30 /65% RH (24 months) and 40 C/75% RH (6 months); in addition stability studies with large scaled batches were started (9 month data available). The bulk batches were stored at 5 C (36 months) and at 25 C/ 60%RH (6 months). The conditions used in the stability studies are according to the ICH stability guideline. The batches were stored in the proposed packaging materials. The drug product demonstrated slight trends at all storage conditions. All batches complied with the specifications. The results of a photostability study showed that the product does not need protection from light. Based on the submitted stability data the proposed shelf life of 36 months without special storage conditions is acceptable. With respect to the bulk blend no trends were observed during storage at long term conditions. A long term (5 C up to 24 hrs.) and accelerated (25 C/60% RH up to 4 hrs.) study was conducted on the reconstituted solution. The solutions used are NaCl 0.9%, dextrose 10%, dextrose 5% with 0.9% sodium bicarbonate, dextrose 5% with 0.9% NaCl, dextrose 5% with 0.15% KCl and Mannitol 10%. The values of the impurities showed significant increased. The assay of Imipenem and Cilastatin decreased, but still comply with the established limits. 4/8

5 The infusion solution in 0.9% NaCl or 5% glucose are acceptable. The diluted solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed 2 hours. Specific measures concerning the prevention of the transmission of animal spongiform encephalopathies There are no substances of ruminant animal origin present in the product nor have any been used in the manufacturing of this product, so a theoretical risk of transmitting TSE can be excluded. II.4 Discussion on chemical, pharmaceutical and biological aspects Based on the submitted dossier, the member states consider that Imipenem/Cilastatine Stravencon 250 mg/250 mg and 500 mg/500 mg have a proven chemical-pharmaceutical quality. Sufficient controls have been laid down for the active substance and finished product. No post-approval commitments were made. III. III.1 NON-CLINICAL ASPECTS Ecotoxicity/environmental risk assessment (ERA) Since this medicine is intended for generic substitution, this will not lead to an increased exposure to the environment. An environmental risk assessment is therefore not deemed necessary. III.2 Discussion on the non-clinical aspects This product is a generic formulation of Tienam, powder for solution for infusion which is available on the European market. Reference is made to the preclinical data obtained with the innovator product. A non-clinical overview on the pharmacology, pharmacokinetics and toxicology has been provided, which is based on up-to-date and adequate scientific literature. The overview justifies why there is no need to generate additional non-clinical pharmacology, pharmacokinetics and toxicology data. Therefore, the member states agreed that no further non-clinical studies are required. IV. IV.1 CLINICAL ASPECTS Introduction Imipenem anhydrate and cilastatin sodium are well-known active substances with established efficacy and tolerability. A clinical overview has been provided, which is based on scientific literature. The overview justifies why there is no need to generate additional clinical data. Therefore, the member states agreed that no further clinical studies are required. IV.2 Pharmacokinetics Biowaiver Imipenem/Cilastatine Stravencon 250 mg/250 mg and 500 mg/500 mg powder for solution for infusion is a parenteral formulation and therefore fulfils the exemption mentioned in the Note for Guidance on bioequivalence parenteral solutions, which states that a bioequivalence study is not required if the product is administered as an aqueous intravenous solution containing the same active substance in the same concentration as the currently authorized reference medicinal product (NfG CPMP/EWP/QWP 1401/98). The quantitative composition of for Imipenem/Cilastatine Stravencon is entirely the same as the originator. Therefore, it may be considered as therapeutic equivalent, with the same efficacy/safety profile as known for the active substance of the reference medicinal product. The current product can be used instead of its reference product. 5/8

6 IV.3 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 Imipenem/Cilastatine Stravencon. The member states agreed that routine pharmacovigilance activities and routine risk minimisation measures are sufficient for the risks and areas of missing information. IV.4 Discussion on the clinical aspects For this authorisation, reference is made to the clinical studies and experience with the innovator product Tienam. No new clinical studies were conducted. Risk management is adequately addressed. This generic medicinal product can be used instead of the reference product. V. USER CONSULTATION 6/8

7 The package leaflet (PL) 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 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. The results show that the persons could find and use the information described in the package leaflet: the test score was 100% in both rounds. The test is of sufficient quality. Based on the results of the testing no suggestions for revision of the package leaflet were provided. This is acceptable in view of the successful user test. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Imipenem/Cilastatine Stravencon 250 mg/250 mg and 500 mg/500 mg powder for solution for infusion have a proven chemical-pharmaceutical quality and are generic/hybrid forms of Tienam powder for solution for infusion 500 mg/500 mg. Tienam is a well-known medicinal product with an established favourable efficacy and safety profile. Since both the reference and current product are intended for parenteral use, no bioequivalence study is deemed necessary. The Board followed the advice of the assessors. There was no discussion in the CMD(h). Agreement between member states was reached during a written procedure. The member states, on the basis of the data submitted, considered that essential similarity has been demonstrated for Imipenem/Cilastatine Stravencon with the reference product, and have therefore granted a marketing authorisation. The decentralized procedure was finalised with a positive outcome on 30 October /8

8 STEPS TAKEN AFTER THE FINALISATION OF THE INITIAL PROCEDURE - SUMMARY Scope Procedure number Type of modification Date of start of the procedure Date of end of the procedure Approval/ non approval Assessment report attached 8/8

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