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Myalepta, INN-Metreleptin 31 May 2018 EMA/435156/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report Myalepta International non-proprietary name: metreleptin Procedure No. EMEA/H/C/004218/0000 Note 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 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure ............................................... 8 1.1. Submission of the dossier ..................................................................................... 8 1.2. Steps taken for the assessment of the product ........................................................ 9 2. Scientific discussion ............................................................................... 11 2.1. Problem statement ............................................................................................. 11 2.1.1. Disease or condition ......................................................................................... 11 2.1.2. Epidemiology .................................................................................................. 11 2.1.3. Biologic features, aetiology and pathogenesis ...................................................... 11 2.1.4. Clinical presentation, diagnosis and stage/prognosis ............................................ 12 2.1.5. Management ................................................................................................... 13 2.2. Quality aspects ................................................................................................... 15 2.2.1. Introduction .................................................................................................... 15 2.2.2. Active Substance ............................................................................................. 15 2.2.3. Finished Medicinal Product ................................................................................ 18 2.2.4. Discussion on chemical, pharmaceutical and biological aspects .............................. 21 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects ....................... 22 2.2.6. Recommendations for future quality development ................................................ 22 2.3. Non-clinical aspects ............................................................................................ 22 2.3.1. Introduction .................................................................................................... 22 2.3.2. Pharmacology ................................................................................................. 22 2.3.3. Pharmacokinetics ............................................................................................. 30 2.3.4. Toxicology ...................................................................................................... 33 2.3.5. Ecotoxicity/environmental risk assessment ......................................................... 45 2.3.6. Discussion on non-clinical aspects ...................................................................... 45 2.3.7. Conclusion on the non-clinical aspects ................................................................ 48 2.4. Clinical aspects ................................................................................................... 48 2.4.1. Introduction .................................................................................................... 48 2.4.2. Pharmacokinetics ............................................................................................. 50 2.4.3. Pharmacodynamics .......................................................................................... 57 2.4.4. Discussion on clinical pharmacology ................................................................... 58 2.4.5. Conclusions on clinical pharmacology ................................................................. 59 2.5. Clinical efficacy .................................................................................................. 59 2.5.1. Dose response study ........................................................................................ 59 2.5.2. Main studies .................................................................................................... 60 2.5.3. Discussion on clinical efficacy ............................................................................ 86 2.5.4. Conclusions on the clinical efficacy ..................................................................... 90 2.6. Clinical safety ..................................................................................................... 91 2.6.1. Discussion on clinical safety ............................................................................ 111 2.6.2. Conclusions on the clinical safety ..................................................................... 115 2.7. Risk Management Plan ...................................................................................... 116 2.8. Pharmacovigilance ............................................................................................ 122 2.9. Product information .......................................................................................... 122 2.9.1. User consultation ........................................................................................... 122 2.9.2. Additional monitoring ..................................................................................... 122 Assessment report EMA/435156/2018 Page 2/136 3. Benefit-Risk Balance ............................................................................ 123 3.1. Therapeutic Context .......................................................................................... 123 3.1.1. Disease or condition ....................................................................................... 123 3.1.2. Available therapies and unmet medical need ..................................................... 123 3.1.3. Main clinical studies ....................................................................................... 123 3.2. Favourable effects ............................................................................................ 124 3.3. Uncertainties and limitations about favourable effects ........................................... 125 3.4. Unfavourable effects ......................................................................................... 125 3.5. Uncertainties and limitations about unfavourable effects ........................................ 126 3.6. Effects Table .................................................................................................... 127 3.7. Benefit-risk assessment and discussion ............................................................... 128 3.7.1. Importance of favourable and unfavourable effects ............................................ 128 3.7.2. Balance of benefits and risks ........................................................................... 128 3.7.3. Additional considerations on the benefit-risk balance .......................................... 129 3.8. Conclusions ..................................................................................................... 130 4. Recommendations ............................................................................... 130 4.1. Conclusions ..................................................................................................... 136 Assessment report EMA/435156/2018 Page 3/136 List of abbreviations ADA Anti-drug antibody ADR Adverse drug reaction AE Adverse event AGL Acquired generalised lipodystrophy ALCL Anaplastic large-cell lymphoma ALT Alanine aminotransferase APC acid precipitation/clarification APL Acquired partial lipodystrophy AST Aspartate aminotransferase AUC Area under the concentration-time curve or analytical ultracentrifugation BID Twice daily BLA Biologics License Application BMI Body mass index BWFI Bacteriostatic water for injection C3 Complement 3 CCI container closure integrity CD circular dichroism CFAS Controlled Concomitant Medication Full Analysis Set CFU colony forming unit CGL Congenital generalised lipodystrophy Cmax Peak serum concentration CQA critical quality attribute CV Coefficient of variation or column volume ECL Electrochemiluminescence EU European Union DP drug product DR diaretentate ELISA enzyme-linked immunosorbent assay EOP end of production EU Endotoxin units FAS Full Analysis Set FDA Food and Drug Administration Assessment report EMA/435156/2018 Page 4/136 FMEA Failure Mode and Effects Analysis FPL Familial partial lipodystrophy FSE full-scale engineering FSG Focal segmental glomerulosclerosis FTIR Fourier transform infrared spectroscopy GL Generalised lipodystrophy HbA1c Glycosylated haemoglobin-specific A1c fraction HCP host cell proteins HDL-C High-density lipoprotein cholesterol HIC hydrophobic interaction chromatography HPLC high performance liquid chromatography HRP horseradish peroxidase HSL N-β-ketocaproyl-DL-homoserine lactone IBs inclusion bodies ICSR Individual Case Safety Reports IND Investigational New Drug IPC in-process control IV Intravenous kbp kilo base pair LAL limulus amoebocyte lysate LC/MS liquid chromatography/mass spectrometry LD Lipodystrophy
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