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Eparations, PDE-4 Enzyme Catalytic Domains, and Full-Length Enzymes Prepared by Recombinant Means Were Characterized

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Eparations, PDE-4 Enzyme Catalytic Domains, and Full-Length Enzymes Prepared by Recombinant Means Were Characterized 30 January 2020 EMA/88816/2020 Committee for Medicinal Products for Human Use (CHMP) Assessment report Staquis International non-proprietary name: crisaborole Procedure No. EMEA/H/C/004863/0000 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 List of abbreviations .................................................................................... 4 1. Background information on the procedure ............................................ 10 1.1. Submission of the dossier .................................................................................... 10 1.2. Steps taken for the assessment of the product ....................................................... 11 2. Scientific discussion .............................................................................. 13 2.1. Problem statement ............................................................................................. 13 2.1.1. Disease or condition ......................................................................................... 13 2.1.2. Epidemiology and risk factors ............................................................................ 13 2.1.3. Aetiology and pathogenesis .............................................................................. 13 2.1.4. Clinical presentation, diagnosis .......................................................................... 14 2.1.5. Management ................................................................................................... 14 2.2. About the product .............................................................................................. 15 2.3. Quality aspects .................................................................................................. 15 2.3.1. Introduction .................................................................................................... 15 2.3.2. Active substance ............................................................................................. 15 2.3.3. Finished medicinal product ................................................................................ 17 2.3.4. Discussion on chemical, and pharmaceutical aspects ............................................ 21 2.3.5. Conclusions on the chemical, pharmaceutical and biological aspects ...................... 21 2.3.6. Recommendation(s) for future quality development ............................................. 21 2.4. Non-clinical aspects ............................................................................................ 21 2.4.1. Pharmacology ................................................................................................. 21 2.4.2. Pharmacokinetics............................................................................................. 24 2.4.3. Toxicology ...................................................................................................... 26 2.4.4. Ecotoxicity/environmental risk assessment ......................................................... 31 2.4.5. Discussion on non-clinical aspects...................................................................... 33 2.4.6. Conclusion on non-clinical aspects ..................................................................... 33 2.5. Clinical aspects .................................................................................................. 34 2.5.1. Introduction .................................................................................................... 34 2.5.2. Pharmacokinetics............................................................................................. 38 2.5.3. Pharmacodynamics .......................................................................................... 49 2.5.4. Discussion on clinical pharmacology ................................................................... 53 2.5.5. Conclusions on clinical pharmacology ................................................................. 55 2.6. Clinical efficacy .................................................................................................. 55 2.6.1. Discussion on clinical efficacy .......................................................................... 106 2.6.2. Conclusions on clinical efficacy ........................................................................ 116 2.7. Risk management plan ...................................................................................... 151 2.8. Pharmacovigilance ............................................................................................ 151 2.9. New Active Substance ....................................................................................... 151 2.10. Product information ........................................................................................ 151 2.10.1. User consultation ......................................................................................... 151 2.10.2. Additional monitoring ................................................................................... 151 Assessment report EMA/88816/2020 Page 2/163 3. Benefit-Risk Balance............................................................................ 152 3.1. Therapeutic Context ......................................................................................... 152 3.2. Available therapies and unmet medical need ........................................................ 152 3.3. Main clinical studies .......................................................................................... 152 3.4. Favourable effects ............................................................................................ 153 3.5. Uncertainties and limitations about favourable effects ........................................... 156 3.6. Unfavourable effects ......................................................................................... 157 3.7. Uncertainties and limitations about unfavourable effects ....................................... 158 3.8. Effects Table .................................................................................................... 159 3.9. Benefit-risk assessment and discussion ............................................................... 160 3.9.1. Importance of favourable and unfavourable effects ............................................ 160 3.10. Balance of benefits and risks ............................................................................ 161 3.11. Additional considerations on the benefit-risk balance .......................................... 162 3.12. Conclusions ................................................................................................... 162 4. Recommendations ............................................................................... 162 Assessment report EMA/88816/2020 Page 3/163 List of abbreviations %F bioavailability AAs Amino acids AAS Atomic Absorption Spectrometry Ac/Et Acetone / Ethanol AD Atopic dermatitis ADSI Atopic Dermatitis Severity Index AE Adverse Event AN2728 Crisaborole AN2898 Anacor Investigational Product AN7602 Metabolite of crisaborole, also referred to as PF-06932648 AN8323 Metabolite of crisaborole, also referred to as PF-06947370 ANOVA Analysis of Variance AP Applicant's Part (or Open Part) of a ASMF API Active Pharmaceutical Ingredient AR Assessment Report ASM Active Substance Manufacturer ASMF Active Substance Master File = Drug Master File ATC Anatomical Therapeutic Chemical Classification System AUC24 Area under the plasma concentration-time curve from 0 to 24 hours postdosing Area under the concentration -time curve from zero to time of last measurable AUClast concentration AUCt Area under the concentration time curve from zero to time t b2pin2 Bis(pinacolato)diboron BCRP Breast cancer resistance protein BHT Butylated hydroxytoluene BID Twice daily administration BLQ Below the limit of quantitation BP Blood pressure BSA Body surface area or Bovine serum albumin cAMP Cyclic adenosine monophosphate CD Clus+B161ter of differentiation CD-1 Cesarean derived CDLQI Children’s Dermatology Life Quality Index cDNA Complimentary deoxyribose nucleic acid CEP Certificate of Suitability of the EP CFU Colony Forming Units cGMP Cyclic guanosine monophosphate CHMP Committee for Medicinal Products for Human Use CHO Chinese hamster ovary Cmax Maximum observed plasma concentration CMC Carboxymethylcellulose CMH Cochran–Mantel–Haenszel CMS Concerned Member State Assessment report EMA/88816/2020 Page 4/163 CNS Central nervous system CoA Certificate of Analysis ConA Concanavalin A COX Cyclooxygenase enzymes CPP Critical process parameter CRS Chemical Reference Substance (official standard) CSR Clinical Study Report CYP Cytochrome P450 DDI Drug-drug interaction DEREK Deductive Estimation of Risk from Existing Knowledge DFI Dermatitis Family Impact Questionnaire DG Gestation Day DLQI Dermatology Life Quality Index DMF Dimethylformamide DMSO Dimethyl sulfoxide DP Decentralised (Application) Procedure DPM Drug Product Manufacturer DSC Differential Scanning Calorimetry DTH Delayed-type hypersensitivity EC50 Concentration corresponding to 50% of the maximum effect ECG Electrocardiogram
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