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Vizamyl, INN-Flutemetamol (18F)

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Vizamyl, INN-Flutemetamol (18F) 26 June 2014 EMA/546752/2014 Committee for Medicinal Products for Human Use (CHMP) Vizamyl flutemetamol (18F) Procedure No. EMEA/H/C/002553 Marketing authorisation holder: GE HEALTHCARE LIMITED Assessment report for an initial marketing authorisation application Assessment report as adopted by the CHMP with all commercially confidential information 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, 2014. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 7 1.1. Submission of the dossier ...................................................................................... 7 1.2. Manufacturers ...................................................................................................... 8 1.3. Steps taken for the assessment of the product ......................................................... 8 2. Scientific discussion ................................................................................ 9 2.1. Introduction......................................................................................................... 9 2.2. Quality aspects .................................................................................................. 11 2.2.1. Introduction .................................................................................................... 11 2.2.2. Active Substance ............................................................................................. 11 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. Recommendation(s) for future quality development ............................................. 15 2.3. Non-clinical aspects ............................................................................................ 16 2.3.1. Introduction .................................................................................................... 16 2.3.2. Pharmacology ................................................................................................. 16 2.3.3. Pharmacokinetics............................................................................................. 18 2.3.4. Toxicology ...................................................................................................... 24 2.3.5. Other studies .................................................................................................. 32 2.3.6. Ecotoxicity/environmental risk assessment ......................................................... 33 2.3.7. Discussion on non-clinical aspects...................................................................... 34 2.3.8. Conclusion on the non-clinical aspects ................................................................ 35 2.4. Clinical aspects .................................................................................................. 35 2.4.1. Introduction .................................................................................................... 35 2.4.2. Pharmacokinetics............................................................................................. 40 2.4.3. Pharmacodynamics .......................................................................................... 45 2.4.4. Discussion on clinical pharmacology ................................................................... 48 2.4.5. Conclusions on clinical pharmacology ................................................................. 51 2.5. Clinical efficacy .................................................................................................. 52 2.5.1. Dose response study(ies) ................................................................................. 52 2.5.2. Main study(ies) ............................................................................................... 52 2.5.3. Discussion on clinical efficacy ............................................................................ 71 2.5.4. Conclusions on the clinical efficacy ..................................................................... 88 2.6. Clinical safety .................................................................................................... 89 Effective Dose............................................................................................ 98 2.6.1. Discussion on clinical safety .............................................................................. 98 2.6.2. Conclusions on the clinical safety ..................................................................... 100 2.7. Pharmacovigilance ............................................................................................ 100 2.8. Risk Management Plan ...................................................................................... 100 2.9. Product information .......................................................................................... 103 2.9.1. User consultation ........................................................................................... 103 Vizamyl EMA/546752/2014 Page 2/108 3. Benefit-Risk Balance............................................................................ 103 4. Recommendations ............................................................................... 106 Vizamyl EMA/546752/2014 Page 3/108 List of abbreviations Aβ Amyloid β AD Alzheimer’s disease AE Adverse event aMCI Amnestic mild cognitive impairment BMI Body mass index AH110690 Non-radioactive analogue of the drug substance [18F]AH110690 18F-labelled drug substance AH110690 (18F) Drug product; the product that is injected containing drug substance and Injection excipients BSS Bielschowsky silver stain CDR Clinical Dementia Rating CER Cerebellum CERAD Consortium to Establish a Registry for Alzheimer’s Disease CI Confidence interval CRF Case Report Form (in paper or electronic format) CRO Contract research organization CSR Clinical study report CT Computed tomography DMS-IV Diagnostic and Statistical Manual of Mental Disorders, 4th Edition DVR Distribution volume ratio E Effective radiation dose (i.e., the sum of risk-weighted organ absorbed radiation dose used as a measure of stochastic radiation risk) ECG Electrocardiogram EMA European Medicines Agency FAS Full analysis set FDA US Food and Drug Administration Flutemetamol F 18 Drug product; the product that is injected containing drug substance and Injection excipients; formerly known as AH110690 F 18 Injection, Drug substance; active component of the investigational medicinal product Flutemetamol (18F) Flutemetamol F 18 Injection. Formerly known as [18F]AH110690. FN False negative Vizamyl EMA/546752/2014 Page 4/108 FP False positive GC Gas chromatography GCP Good Clinical Practice HPLC High performance liquid chromatography HV Healthy volunteer IBRI Institute of Biomedical Research and Information ICH International Conference on Harmonization IEC Independent ethics committee IHC Immunohistochemical, immunohistochemistry IMP Investigational medicinal product IRB Institutional/independent review board ISE Integrated Summary of Effectiveness i.v. Intravenous Max Maximum MBq Megabecquerel(s) mCi Millicurie(s) MCI Mild cognitive impairment mGy MilliGray Min Minimum MIRD Medical Internal Radiation Dose mL Milliliter MMSE Mini-Mental State Examination MRI Magnetic resonance imaging MS Mass spectrometry NIA National Institute on Aging National Institute of Neurological and Communicative Disorders and Stroke; NINCDS-ADRDA Alzheimer’s Disease and Related Disorders Association NPH Normal pressure hydrocephalus OLINDA/EXM Organ Level Internal Dosimetry Assessment/Exponential Modeling pAD Probable Alzheimer’s disease PCNS Peripheral and central nervous system PET Positron emission tomography Vizamyl EMA/546752/2014 Page 5/108 Ph. Eur. European Pharmacopoeia p.i. Post injection PiB Pittsburgh compound B RAC Radioactive concentration ROI Region of interest QC Quality Control SAE Serious adverse event SCE Summary of Clinical Efficacy SD Standard deviation SOP Standard operating procedure SoT Standard of truth SUV Standard uptake value SUVR Standardized uptake value ratio. The SUVR is a quantitative measure of amyloid-specific flutemetamol (18F) uptake, normalized for the mean non-specific uptake in a reference region (cerebellum or pons). SUVR is defined as SUVVOI/SUVREF with SUV being the integrated activity over a given time period per unit of injected dose and body weight. When the cerebellum is used as the reference region, cortical regions lacking in amyloid are expected to have SUVR near 1, and cortical regions rich in amyloid are expected to have SUVR greater than 1. When used without qualification, SUVR refers to SUVR-CER (SUVR with the cerebellum as the reference region). A composite SUVR is the simple average of the SUVR in multiple regions SUVR-CER SUVR using the cerebellum as the reference region SUVR-PONS SUVR using the pons as the reference region TLC Thin layer chromatography TN True negative TP True positive UR Uptake ratio US United States VOI Volume of interest Vizamyl EMA/546752/2014 Page 6/108 1. Background information on the procedure
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