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Relvar Ellipta, Revinty Ellipta, INN-Fluticasone Furoate / Vilanterol

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Relvar Ellipta, Revinty Ellipta, INN-Fluticasone Furoate / Vilanterol 25 January 2018 EMA/CHMP/187802/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report Revinty Ellipta fluticasone furoate / vilanterol Relvar Ellipta fluticasone furoate / vilanterol Procedure No. EMEA/H/C/xxxx/WS/1208 Note Variation assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Sen d a question via our website www.ema.europa.eu/contact An agency of the European Union Table of contents 1. Background information on the procedure .............................................. 3 1.1. Type II variation .................................................................................................. 3 1.2. Steps taken for the assessment of the product ........................................................ 3 2. Scientific discussion ................................................................................ 4 2.1. Introduction ........................................................................................................ 4 2.2. Non-clinical aspects .............................................................................................. 4 2.3. Clinical aspects .................................................................................................... 5 2.3.1. Introduction...................................................................................................... 5 2.3.2. Main study -Study 201378 ................................................................................. 5 2.3.3. Supportive study -Study 201135 ....................................................................... 21 2.3.4. Discussion on efficacy ...................................................................................... 28 2.3.5. Conclusion on efficacy ...................................................................................... 30 2.4. Clinical Safety .................................................................................................... 30 2.4.1. Discussion on safety ........................................................................................ 33 2.4.2. PSUR cycle ..................................................................................................... 33 2.5. Update of the Product information ........................................................................ 33 2.5.1. User consultation ............................................................................................ 33 3. Benefit-Risk Balance ............................................................................. 34 3.1. Therapeutic Context ........................................................................................... 34 3.1.1. Disease or condition ........................................................................................ 34 3.1.2. Available therapies and unmet medical need ....................................................... 34 3.1.3. Main clinical studies ......................................................................................... 35 3.2. Favourable effects .............................................................................................. 35 3.3. Uncertainties and limitations about favourable effects ............................................. 36 3.4. Unfavourable effects ........................................................................................... 36 3.5. Uncertainties and limitations about unfavourable effects ......................................... 37 3.6. Effects Table ...................................................................................................... 37 3.7. Benefit-risk assessment and discussion ................................................................. 38 3.7.1. Importance of favourable and unfavourable effects .............................................. 38 3.7.2. Balance of benefits and risks ............................................................................ 38 3.8. Conclusions ....................................................................................................... 38 4. Recommendations ................................................................................. 39 5. EPAR changes ....................................................................................... 39 Assessment report EMA/CHMP/187802/2018 Page 2/39 1. Background information on the procedure 1.1. Type II variation Pursuant to Article 16 of Commission Regulation (EC) No 1234/2008, Glaxo Group Ltd submitted to the European Medicines Agency on 21 July 2017 an application for a variation following a worksharing procedure according to Article 20 of Commission Regulation (EC) No 1234/2008. The following variation was requested: Variation requested Type Annexes affected C.I.6.a C.I.6.a - Change(s) to therapeutic indication(s) - Addition Type II I of a new therapeutic indication or modification of an approved one Extension of Indication for Relvar Ellipta and Revinty Ellipta to include treatment of patients with asthma already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist. As a consequence, sections 4.1 and 5.1 of the SmPC are updated. The requested worksharing procedure proposed amendments to the Summary of Product Characteristics and Package leaflet. Information on paediatric requirements Pursuant to Article 8 of Regulation (EC) No 1901/2006, the application included an EMA Decision(s) P/0157/2017 on the agreement of a paediatric investigation plan (PIP). At the time of submission of the application, the PIP P/0157/2017 was not yet completed as some measures were deferred. Information relating to orphan market exclusivity Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000 and Article 3 of Commission Regulation (EC) No 847/2000, the applicant did not submit a critical report addressing the possible similarity with authorised orphan medicinal products because there is no authorised orphan medicinal product for a condition related to the proposed indication. Scientific advice The applicant did not seek Scientific Advice at the CHMP. 1.2. Steps taken for the assessment of the product Appointed Rapporteur for the WS procedure: Concepcion Prieto Yerro Assessment report EMA/CHMP/187802/2018 Page 3/39 Timetable Actual dates Submission date 21 July 2017 Start of procedure: 12 August 2017 CHMP Rapporteur Assessment Report 6 October 2017 CHMP members comments 30 October 2017 Request for supplementary information (RSI) 9 November 2017 CHMP Rapporteur Assessment Report 8 January 2018 CHMP members comments 15 January 2018 Updated CHMP Rapporteur Assessment Report 24 January 2018 Opinion 25 January 2018 2. Scientific discussion 2.1. Introduction Relvar and Revinty Ellipta 100 µg/25 µg & 200 µg/25 µg inhalation powder are a pre-dispensed multi dose dry powder for oral inhalation. The active ingredients are fluticasone furoate (FF) and Vilanterol (VI) (as trifenatate). FF is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity, while VI is a selective long-acting, beta2-adrenergic agonist (LABA). On 13th November 2013, Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) was approved by the European Commission for the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate, patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short- acting beta2-agonists” as well as for the symptomatic treatment of patients with chronic obstructive pulmonary disease (COPD). GlaxoSmithKline (GSK) is submitting this application to update the Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder label based on the data from Study 201378. Study 201378 provides data from subjects adequately controlled with an ICS/LABA equivalent to fluticasone propionate/salmeterol [FP/SAL] 250/50 twice daily [BD]) who were randomized to 24 weeks of treatment with FF/VI 100/25 once daily (OD), FP/SAL 250/50 BD, or FP 250 BD. 2.2. Non-clinical aspects No new clinical data have been submitted in this application, which was considered acceptable by the CHMP. An updated ERA was submitted and discussed during the procedure. The new indication is not anticipated to change previous conclusion and Relvar Ellipta is not expected to pose a risk on the environment. Assessment report EMA/CHMP/187802/2018 Page 4/39 2.3. Clinical aspects 2.3.1. Introduction Two efficacy studies have been submitted in this variation. The applicant's request for section 4.1 and 5.1. is based on study 201378 and Study 201135 as Supporting efficacy data. The primary objective of Study 201378 was to demonstrate non-inferiority of RELVAR ELLIPTA 100/25 OD to SERETIDE ACCUHALER/DISKUS 250/50 BD in subjects with persistent bronchial asthma adequately controlled on twice daily ICS/LABA. While the primary comparison in Study 201378 was of FF/VI with FP/SAL, the inclusion of FP allowed for the demonstration of assay sensitivity within the study. Data from the open-label Period 1 of Study 201135 is presented as supporting data. The objective of Period 1 in Study 201135 was to evaluate the effect on maintenance of asthma control when subjects were switched from ICS/LABA (equivalent to FP/SAL 250/50 BD) to 8 weeks of treatment with FF/VI 100/25 OD. The objective of Period 2 was to evaluate the effect of FF 100 mcg on maintenance
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