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25 June 2020 EMA/200048/2020 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pretomanid FGK International non-proprietary name: pretomanid Procedure No. EMEA/H/C/005167/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier ...................................................................................... 6 1.2. Steps taken for the assessment of the product ......................................................... 7 2. Scientific discussion ................................................................................ 9 2.1. Problem statement ............................................................................................... 9 2.1.1. Disease or condition ........................................................................................... 9 2.1.2. Management ..................................................................................................... 9 2.2. Quality aspects .................................................................................................. 10 2.2.1. Introduction .................................................................................................... 10 2.2.2. Active Substance ............................................................................................. 10 2.2.3. Finished Medicinal Product ................................................................................ 13 2.2.4. Discussion on chemical, pharmaceutical and biological aspects .............................. 15 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects ...................... 15 2.2.6. Recommendations for future quality development................................................ 15 2.3. Non-clinical aspects ............................................................................................ 15 2.3.1. Introduction .................................................................................................... 15 2.3.2. Pharmacology ................................................................................................. 16 2.3.3. Pharmacokinetics............................................................................................. 19 2.3.4. Toxicology ...................................................................................................... 22 2.3.5. Ecotoxicity/environmental risk assessment ......................................................... 27 2.3.6. Discussion on non-clinical aspects...................................................................... 29 2.3.7. Conclusion on the non-clinical aspects ................................................................ 32 2.4. Clinical aspects .................................................................................................. 33 2.4.1. Introduction .................................................................................................... 33 2.4.2. Pharmacokinetics............................................................................................. 33 2.4.3. Pharmacodynamics .......................................................................................... 40 2.4.4. Discussion on clinical pharmacology ................................................................... 47 2.4.5. Conclusions on clinical pharmacology ................................................................. 51 2.5. Clinical efficacy .................................................................................................. 52 2.5.1. Dose response studies...................................................................................... 57 Supportive study ...................................................................................................... 76 2.5.2. Discussion on clinical efficacy ............................................................................ 80 2.5.3. Conclusions on the clinical efficacy ..................................................................... 82 2.6. Clinical safety .................................................................................................... 82 2.6.1. Discussion on clinical safety ............................................................................ 106 2.7. Risk Management Plan ...................................................................................... 110 2.8. Pharmacovigilance ............................................................................................ 112 2.9. New Active Substance ....................................................................................... 112 2.10. Product information ........................................................................................ 113 2.10.1. User consultation ......................................................................................... 113 2.10.2. Labelling exemptions .................................................................................... 113 2.10.3. Additional monitoring ................................................................................... 113 EMA/200048/2020 Page 2/121 3. Benefit-Risk Balance............................................................................ 114 3.1. Therapeutic Context ......................................................................................... 114 3.1.1. Disease or condition ....................................................................................... 114 3.1.2. Available therapies and unmet medical need ..................................................... 114 3.1.3. Main clinical studies ....................................................................................... 114 3.2. Favourable effects ............................................................................................ 115 3.3. Uncertainties and limitations about favourable effects ........................................... 115 3.4. Unfavourable effects ......................................................................................... 115 3.5. Uncertainties and limitations about unfavourable effects ....................................... 116 3.6. Benefit-risk assessment and discussion ............................................................... 117 3.6.1. Importance of favourable and unfavourable effects ............................................ 117 3.6.2. Balance of benefits and risks ........................................................................... 118 3.6.3. Additional considerations on the benefit-risk balance ......................................... 118 3.7. Conclusions ..................................................................................................... 119 4. Recommendations ............................................................................... 119 EMA/200048/2020 Page 3/121 List of abbreviations ALT alanine aminotransferase ANC absolute neutrophil count AREDS2 Age-Related Eye Disease Study 2 AS Active substance AST aspartate aminotransferase B bedaquiline (formerly J, TMC207) BCS Biopharmaceutics Classification System BPaL bedaquiline, pretomanid, and linezolid regimen C Clofazimine CHMP Committee for Medicinal Products for Human use CSR clinical study report DoE Design of experiments DR drug resistant DS drug susceptible E Ethambutol EBA early bactericidal activity eDISH evaluation of drug-induced serious hepatotoxicity GC gas chromatography GGT gamma-glutamyltransferase H Isoniazid HPLC high performance liquid chromatography HRZE isoniazid, rifampicin, pyrazinamide, and ethambutol regimen HDTMA Hexadecyltrimethyl-Ammonium Bromide HM LDPE high molecular low density polyethylene ICH International Conference on Harmonisation IR infra red spectroscopy KF Karl Fischer titration L Linezolid LDPE low density polyethylene M Moxifloxacin MDR-TB multidrug-resistant TB (resistance to H and R) MGIT mycobacterial growth indicator tube EMA/200048/2020 Page 4/121 MS mass spectrometry MTB Mycobacterium tuberculosis NLT not less than NMR nuclear magnetic resonance NMT not more than Pa Pretomanid Ph. Eur. European Pharmacopoeia pre-XDR-TB pre-extensively DR TB (resistance to H + R + quinolone or injectable) PVC Polyvinyl chloride PVDC Polyvinylidene chloride QbD Quality by design QTc QT interval corrected for heart rate QTcF QT interval corrected for heart rate using Fridericia’s method QTPP Quality target product profile R Rifampicin RH relative humidity SmPC Summary of Product Characteristics TB Tuberculosis TB Alliance Global Alliance for TB Drug Development TEAE treatment-emergent adverse event TI MDR-TB treatment-intolerant multidrug-resistant tuberculosis TI/NR MDR-TB treatment-intolerant/nonresponsive tuberculosis TSE Transmissible Spongiform Encephalopathy UV ultra violet spectrometry XR(P)D X-Ray (Powder) Diffraction XDR-TB extensively drug-resistant (resistance to H + R + fluoroquinolone + injectable) Z Pyrazinamide EMA/200048/2020 Page 5/121 1. Background information on the procedure 1.1. Submission of the dossier The applicant FGK Representative Service GmbH submitted
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