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Xiidra, INN-Lifitegrast EMA/334174/2020 Committee for Medicinal Products for Human Use (CHMP) Withdrawal assessment report Xiidra International non-proprietary name: lifitegrast Procedure No. EMEA/H/C/004653/0000 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. Classified as confidential by the European Medicines Agency Table of Contents 1. Joint Rapporteur’s Recommendations ..................................................... 5 2. Executive summary ................................................................................. 7 2.1. Problem statement ............................................................................................... 7 2.1.1. Disease or condition ........................................................................................... 7 2.1.2. Epidemiology and risk factors, screening tools/prevention ...................................... 7 2.1.3. Aetiology and pathogenesis ................................................................................ 7 2.1.4. Clinical presentation ........................................................................................... 8 2.1.5. Management ..................................................................................................... 8 2.2. About the product ................................................................................................ 9 2.3. General comments on compliance with GMP, GLP, GCP ............................................. 9 2.4. Type of application and other comments on the submitted dossier............................ 10 3. Scientific overview and discussion ........................................................ 11 3.1. Quality aspects .................................................................................................. 11 3.1.1. Introduction .................................................................................................... 11 3.1.2. Active Substance ............................................................................................. 11 3.1.3. Finished Medicinal Product ................................................................................ 14 3.1.4. Discussion and conclusions on chemical, pharmaceutical and biological aspects ....... 16 3.2. Non clinical aspects ............................................................................................ 16 3.2.1. Pharmacology ................................................................................................. 16 3.2.2. Pharmacokinetics............................................................................................. 20 3.2.3. Toxicology ...................................................................................................... 24 3.2.4. Ecotoxicity/environmental risk assessment ......................................................... 32 3.2.5. Discussion on non-clinical aspects...................................................................... 32 3.2.6. Conclusion on non-clinical aspects ..................................................................... 33 3.3. Clinical aspects .................................................................................................. 33 3.3.1. Pharmacokinetics............................................................................................. 35 3.3.2. Pharmacodynamics .......................................................................................... 42 3.3.3. Discussion on clinical pharmacology ................................................................... 43 3.3.4. Conclusions on clinical pharmacology ................................................................. 45 3.3.5. Clinical efficacy ............................................................................................... 46 3.3.6. Discussion on clinical efficacy ............................................................................ 91 3.3.7. Conclusions on clinical efficacy .......................................................................... 98 3.3.8. Clinical safety .................................................................................................. 98 3.3.9. Discussion on clinical safety ............................................................................ 115 3.3.10. Conclusions on clinical safety ........................................................................ 116 3.4. Risk management plan ...................................................................................... 116 3.4.1. Safety Specification ....................................................................................... 116 3.4.2. Discussion on safety specification .................................................................... 117 3.4.3. Conclusions on the safety specification ............................................................. 117 3.4.4. Pharmacovigilance plan .................................................................................. 117 3.4.5. Risk minimisation measures ............................................................................ 118 3.4.6. Conclusion on the RMP ................................................................................... 120 3.5. Pharmacovigilance system ................................................................................. 120 XIIDRA EMA/334174/2020 Page 2/125 4. Benefit risk assessment ....................................................................... 120 4.1. Therapeutic Context ......................................................................................... 120 4.1.1. Disease or condition ....................................................................................... 120 4.1.2. Available therapies and unmet medical need ..................................................... 121 4.1.3. Main clinical studies ....................................................................................... 121 4.2. Favourable effects ............................................................................................ 121 4.3. Uncertainties and limitations about favourable effects ........................................... 121 4.4. Unfavourable effects ......................................................................................... 122 4.5. Uncertainties and limitations about unfavourable effects ....................................... 122 4.6. Effects Table .................................................................................................... 123 4.7. Benefit-risk assessment and discussion ............................................................... 125 4.7.1. Importance of favourable and unfavourable effects ............................................ 125 4.7.2. Balance of benefits and risks ........................................................................... 125 4.7.3. Additional considerations on the benefit-risk balance ......................................... 125 4.8. Conclusions ..................................................................................................... 125 XIIDRA EMA/334174/2020 Page 3/125 List of abbreviations AE adverse event ANCOVA analysis of covariance ANOVA analysis of variance ATs artificial tears AUC area under the curve AUC0-t area under the curve from the time of dosing to the last measurable concentration BCVA best corrected visual acuity BID twice daily CAE controlled adverse environment CAE controlled adverse environment CFR Code of Federal Regulations CSR clinical study report Cmax maximum concentration occurring at tmax DED dry eye disease EDS eye dryness score FDA Food and Drug Administration GCP Good Clinical Practice ICH International Council on Harmonisation ICSS inferior corneal staining score IOP intraocular pressure ISE integrated summary of efficacy ITT intent-to-treat LIF Lifitegrast LOCF last observation carried forward ODS ocular discomfort score OSDI Ocular Surface Disease Index (Allergan, Inc.) PBO Placebo RMP Risk Management Plan SE standard error STT Schirmer Tear Test TEAE treatment-emergent adverse event US United States VAS visual analogue scale VR-OSDI visual-related function subscale of Ocular Surface Disease Index XIIDRA EMA/334174/2020 Page 4/125 1. Joint Rapporteur’s Recommendations Based on the review of the data on quality, safety, efficacy, the application for Xiidra eye drop for the treatment of moderate to severe dry eye disease in adults for whom artificial tears has not been sufficient is not approvable since "major objections" have been identified, which preclude a recommendation for marketing authorisation at the present time. The details of these major objections are provided in the 2nd List of Outstanding Issues (see section VI). In addition, satisfactory answers must be given to the "other concerns" as detailed in the List of Questions. The major objections precluding a recommendation of marketing authorisation, pertain to the following principal deficiencies: Clinical: Three clinical major objections have been raised. One relates to the lack of convincingly demonstration of clinically relevant effect across the different symptoms related to DED. The other clinical major objection regards
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