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Ozempic, INN-Semaglutide 14 December 2017 EMA/CHMP/715701/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report Ozempic International non-proprietary name: semaglutide Procedure No. EMEA/H/C/004174/0000 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. Administrative information Name of the medicinal product: Ozempic Applicant: Novo Nordisk A/S Novo Allé 1 DK-2880 Bagsvaerd Denmark Active substance: semaglutide International Non-proprietary Name/Common semaglutide Name: Pharmaco-therapeutic group blood glucose lowering drugs, excl. insulins, (ATC Code): (A10BJ06) Therapeutic indications: Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. Pharmaceutical form: solution for injection Strength: 1.34 mg/ml Route of administration: subcutaneous use Packaging: cartridge (glass) in pre-filled pen Package size: 1 pre-filled pen + 6 needles Ozempic Assessment report EMA/CHMP/715701/2017 Page 2/156 Table of contents 1. Background information on the procedure .............................................. 7 1.1. Submission of the dossier ...................................................................................... 7 1.2. Steps taken for the assessment of the product ......................................................... 8 2. Scientific discussion ................................................................................ 9 2.1. Problem statement ............................................................................................... 9 2.1.1. Disease or condition ........................................................................................... 9 2.1.2. Epidemiology and risk factors ............................................................................ 10 2.1.3. Biologic features .............................................................................................. 10 2.1.4. Available therapies and unmet medical need ....................................................... 10 2.1.5. About the product ............................................................................................ 11 2.2. Quality aspects .................................................................................................. 11 2.2.1. Introduction .................................................................................................... 11 2.2.2. Active Substance ............................................................................................. 12 2.2.3. Finished Medicinal Product ................................................................................ 15 2.2.4. Discussion on chemical, pharmaceutical and biological aspects .............................. 18 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects ...................... 19 2.2.6. Recommendation for future quality development ................................................. 20 2.3. Non-clinical aspects ............................................................................................ 20 2.3.1. Introduction .................................................................................................... 20 2.3.2. Pharmacology ................................................................................................. 20 2.3.3. Pharmacokinetics............................................................................................. 23 2.3.4. Toxicology ...................................................................................................... 26 2.3.5. Ecotoxicity/environmental risk assessment ......................................................... 29 2.3.6. Discussion on non-clinical aspects...................................................................... 29 2.3.7. Conclusion on non-clinical aspects ..................................................................... 30 2.4. Clinical aspects .................................................................................................. 30 2.4.1. Introduction .................................................................................................... 30 2.4.2. Pharmacokinetics............................................................................................. 33 2.4.3. Pharmacodynamics .......................................................................................... 40 Cardiac repolarisation by QT interval evaluation ............................................................ 44 Exposure-response analyses ...................................................................................... 46 2.4.4. Discussion on clinical pharmacology ................................................................... 48 2.4.5. Conclusions on clinical pharmacology ................................................................. 53 2.5. Clinical efficacy .................................................................................................. 53 2.5.1. Dose selection, dose response studies ................................................................ 53 2.5.2. Main studies ................................................................................................... 54 2.5.3. Discussion on clinical efficacy ............................................................................ 96 2.5.4. Conclusions on clinical efficacy ........................................................................ 104 2.5.5. Clinical safety ................................................................................................ 105 Patient exposure ..................................................................................................... 105 Ozempic Assessment report EMA/CHMP/715701/2017 Page 3/156 Adverse events ....................................................................................................... 105 Serious adverse events and deaths ........................................................................... 107 Adverse events of special interest ............................................................................. 108 Laboratory findings ................................................................................................. 124 Safety in special populations .................................................................................... 124 Immunological events ............................................................................................. 126 Safety related to drug-drug interactions and other interactions ..................................... 127 Discontinuation due to AES ...................................................................................... 127 Post marketing experience ....................................................................................... 127 2.5.6. Discussion on clinical safety ............................................................................ 127 2.5.7. Conclusions on clinical safety .......................................................................... 135 2.6. Risk Management Plan ...................................................................................... 135 2.7. New Active Substance ....................................................................................... 139 2.8. Product information .......................................................................................... 139 2.8.1. User consultation ........................................................................................... 139 2.8.2. Additional monitoring ..................................................................................... 139 3. Benefit risk assessment ....................................................................... 139 3.1. Therapeutic Context ......................................................................................... 139 3.1.1. Disease or condition ....................................................................................... 139 3.1.2. Available therapies and unmet medical need ..................................................... 139 3.1.3. Main clinical studies ....................................................................................... 140 3.2. Favourable effects ............................................................................................ 141 3.3. Uncertainties and limitations about favourable effects ........................................... 142 3.4. Unfavourable effects ......................................................................................... 145 3.5. Uncertainties and limitations about unfavourable effects ....................................... 147 3.6. Effects Table .................................................................................................... 151 3.7. Benefit-risk assessment and discussion ............................................................... 152 3.7.1. Importance of favourable
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