| OPPOSITION | - Anonymous, "Assessment report - Cosentyx - International non-proprietary name: secukinumab", EMA; Procedure No. EMEA/H/C/003729, (20141120), EMA; Procedure No. EMEA/H/C/003729, URL: https://www.ema.europa.eu/en/documents/assessment-report/cosentyx-epar-public-assessment-report_en.pdf, XP093281191 | - |
| OPPOSITION | - Anonymous, "COSENTYX ® (secukinumab) for injection, for subcutaneous use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20160101), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf, XP093281198 | - |
| OPPOSITION | - Anonymous, "Cosentyx - Summary of Product Characteristics", EMA, (20150101), XP093281199 | - |
| OPPOSITION | - Anonymous, "COSENTYX TM (secukinumab) for injection, for subcutaneous use - HIGHLIGHTS OF PRESCRIBING INFORMATION", FDA, (20150101), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf, XP093281150 | - |
| OPPOSITION | - Anonymous, "FDA approves new psoriasis drug Cosentyx", FDA News Release, (20150121), pages 1 - 3, FDA News Release, URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430969.htm, (20170112), XP055334954 | - |
| OPPOSITION | - Anonymous, "Novartis announces FDA approval for first IL-17A antagonist Cosentyx(TM) (secukinumab) for moderate-to-severe plaque psoriasis patients", Novartis, (20150121), Novartis, URL: https://www.novartis.com/news/media-releases/novartis-announces-fda-approval-first-il-17a-antagonist-cosentyxtm-secukinumab-moderate-severe-plaque-psoriasis-patients#:~:text=Basel%2C%20January%2021%2C%202015%20%2D,bloodstream%20and%20distributed%20to%20all, XP093281225 | - |
| OPPOSITION | - Anonymous, "Novartis' Cosentyx is first and only IL-17A inhibitor to potentially modify the course of psoriasis", Novartis, (20170321), Novartis, URL: https://www.novartis.com/news/media-releases/novartis-cosentyx-first-and-only-il-17a-inhibitor-potentially-modify-course-psoriasis, XP093281175 | - |
| OPPOSITION | - Anonymous, "Novartis Cosentyx(TM) is the first IL-17 inhibitor to receive EU approval for firstline treatment of moderate-to-severe psoriasis patients", Novartis, (20150119), Novartis, URL: https://www.novartis.com/news/media-releases/novartis-cosentyxtm-first-il-17-inhibitor-receive-eu-approval-first-line-treatment-moderate-severe-psoriasis-patients, XP093281187 | - |
| OPPOSITION | - Anonymous, "Psoriasis - The assessment and management of psoriasis ", National Institute for Health and Clinical Excellence; NICE clinical guideline 153, (20121001), XP093281185 | - |
| OPPOSITION | - Armstrong April W, Vender Ron, Kircik Leon, "Secukinumab in the Treatment of Palmoplantar, Nail, Scalp, and Pustular Psoriasis a", J CLIN AESTHET DERMATOL, (20160601), vol. 9, no. 6, pages S12 - S16, XP093281249 | - |
| OPPOSITION | - D22 - Novartis Financial Results, published 27 October 2015 | - |
| OPPOSITION | - D28 - Compilation of screen shots of complete ClinicalTrials.gov archive website regarding record history entry #19 on ERASURE study of January 19, 2016 | - |
| OPPOSITION | - D29 - Compilation of screen shots of complete ClinicalTrials.gov archive website regarding record history entry #25 on FIXTURE study of January 19, 2016 | - |
| OPPOSITION | - D33 - Evidence of publication date of D20 | - |
| OPPOSITION | - D38 - Cosentyx® European Approval and Summary of Product Characteristics | - |
| OPPOSITION | - D60 - FDA Advisory Committee Recommends Approval of Secukinumab for Plaque Psoriasis | - |
| OPPOSITION | - D63 - Langley, "Langley 2014 Supplementary Appendix"N EnglJ Med, September 2014 | - |
| OPPOSITION | - D65 - EU Clinical Trials Register, "Efficacy of Secukinumab Compared to Ustekinumab" 06.12.2013 | - |
| OPPOSITION | - D66 - EU Clinical Trials Register, "CAIN457A2322 Clinical Trials Register" 11.01.2017 | - |
| OPPOSITION | - D67 - EU Clinical Trials Register, "CAIN457A2304 Clinical Trials Register" 27.05.2011 | - |
| OPPOSITION | - Fala Loretta, "Cosentyx (Secukinumab): First IL-17A Antagonist Receives FDA Approval for Moderate-to-Severe Plaque Psoriasis", American Health & Drug Benefits, (20160301), vol. 9, pages 60 - 63, XP093006366 | - |
| OPPOSITION | - Garde Damian, "Novartis Cosentyx(TM) receives positive CHMP opinion for first-line treatment of moderate-tosevere psoriasis patients", FiercePharma, (20141121), FiercePharma, URL: https://www.fiercebiotech.com/biotech/novartis-cosentyx-tm-receives-positive-chmp-opinion-for-first-line-treatment-of-moderate-to, XP093281213 | - |
| OPPOSITION | - Goodless Dean, "What Conditions Can Be Mistaken For Psoriasis? 8 Skin Issues That Can Mimic Psoriasis", verywellhealth, (20241231), verywellhealth, URL: https://www.verywellhealth.com/mimics-of-psoriasis-2788343, XP093281238 | - |
| OPPOSITION | - Gottlieb Alice B, Sigurgeirsson Bardur, Blauvelt Andrew, Mpfofu Shephard, Martin Ruvie, Charis Papavassilis, "Secukinumab Shows Substantial Improvement In Both Psoriasis Symptoms and Physical Functioning In Moderate- To-Severe Plaque Psoriasis Patients With Psoriatic Arthritis: A Subanalysis Of a Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study (Abstract Number 319)", AMERICAN COLLEGE OF RHEUMATOLOGY, 2013, (20130101), AMERICAN COLLEGE OF RHEUMATOLOGY, 2013, URL: https://acrabstracts.org/abstract/secukinumab-shows-substantial-improvement-in-both-psoriasis-symptoms-and-physical-functioning-in-moderate-to-severe-plaque-psoriasis-patients-with-psoriatic-arthritis-a-subanalysis-of-a-phase-3-mult/, XP093281247 | - |
| OPPOSITION | - Hui-Zi Xiong, Gu Jun-Ying, He Zhi-Gang, Chen Wen-Juan, Zhang Xiao, Wang Jia-Yi, Shi Yu-Ling, "Efficacy and safety of secukinumab in the treatment of moderate to severe plaque psoriasis: a meta-analysis of randomized controlled trials", Int J Clin Exp Med, (20150330), vol. 8, no. 3, pages 3156 - 3172, XP055302908 | - |
| OPPOSITION | - Kirkham Bruce, De Vlam Kurt, Li Wenzhi, Boggs Robert, Mallbris Lotus, Nab Henk W, Tarallo Miriam, "Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: Findings from the etanercept PRESTA trial", CLINICAL AND EXPERIMENTAL RHEUMATOLOGY., PACINI, PISA, IT, IT , (20150101), vol. 33, no. 1, ISSN 0392-856X, pages 11 - 19, XP093281162 | - |
| OPPOSITION | - Lebwohl M, Iversen L, Eidsmo L, Messina I, You R, Milutinovic M, "Long-term Psoriasis Control Following Secukinumab Discontinuation Indicates Disease Modification of Moderate to Severe Psoriasis", J Clin Aesthet Dermatol, (20170501), vol. 10, no. 5, pages S28 - S29, XP093281209 | - |
| OPPOSITION | - Leonardi Craig, Akimichi Morita, Hanno Richards, Helen Jane Thurston, "P6512 Secukinumab efficacy in moderate to severe psoriasis appears not to be affected by previous biologic use: Results of a phase II, dose-ranging trial", J Am Acad Dermatol, (20130401), page AB211, XP093281207 | - |
| OPPOSITION | - LUBA KELLY M, STULBERG D L, "Chronic plaque psoriasis.", AMERICAN FAMILY PHYSICIAN, American Academy of Family Physicians, US, US , (20060215), vol. 73, no. 4, ISSN 0002-838X, pages 636 - 644, XP002601002 | - |
| OPPOSITION | - Marcin Ashley, "What Conditions Can Be Misdiagnosed as Psoriasis?", healthline, (20220801), healthline, URL: https://www.healthline.com/health/psoriasis-misdiagnosis, XP093281242 | - |
| OPPOSITION | - Novartis Pharmaceuticals, "Study of the Ecacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis (STEPin) - NCT03020199", Clinical Trials, clinicaltrials.gov, (20170509), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT03020199?term=NCT03020199&rank=1&a=2, XP093281169 | - |
| OPPOSITION | - Papp Kim, Karpov Alexander, Papavassilis Charis, Melendez Esperanza, Hidemi Nakagawa, "P8011 Secukinumab efficacy in relationship with response to previous biologic psoriasis therapy: A subanalysis from the ERASURE Study", J Amer Acad Dermatol, (20140501), vol. 70, no. 5, page AB186, XP093281231 | - |
| OPPOSITION | - Wharton Keith Jr; Krueger James; Fuentes-Duculan Judilyn; Wang Claire; Hillenbrand Rainer; Li Yue; Koroleva Irina; Hueber Wolfgang, "Secukinumab Reverses Disease-Defining Psoriasis Histopathology While Retaining Full T-cell Activation Potential", The FASEB Journal, Federation of American Societies for Experimental Biology, US, US, (20150331), vol. 29, no. Suppl. 1, ISSN 0892-6638, page LB443, XP009500504 | - |
| OPPOSITION | - Breedveld F C, Weisman M H, Kavanaugh A F, Cohen S B, Pavelka K, van Vollenhoven R, Sharp J, Perez J L, Spencer-Green G T, "The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment.", Arthritis & Rheumatism, Wiley InterScience, US, US , (20060101), vol. 54, no. 1, doi:10.1002/art.21519, ISSN 0004-3591, pages 26 - 37, XP002742040 | |
| OPPOSITION | - Tom Hartwig; Stanislav Pantelyushin; Andrew L. Croxford; Paulina Kulig; Burkhard Becher, "Dermal IL‐17‐producing γδ T cells establish long‐lived memory in the skin", European Journal of Immunology, Wiley-VCH, Hoboken, USA, Hoboken, USA, (20151019), vol. 45, no. 11, doi:10.1002/eji.201545883, ISSN 0014-2980, pages 3022 - 3033, XP071227483 | |
| OPPOSITION | - Augustin et al., "The German National Program on Psoriasis Health Care 2005-2015: results and experiences", Arch Dermatol Res , (2016), vol. 308, doi:10.1007/s00403-016-1637-8, XP036001781 | |
| OPPOSITION | - Gisondi Paolo, Dalle Vedove Camilla, Girolomoni Giampiero, "Efficacy and Safety of Secukinumab in Chronic Plaque Psoriasis and Psoriatic Arthritis Therapy", Dermatology and Therapy, (20140601), vol. 4, no. 1, doi:10.1007/s13555-014-0042-5, ISSN 2193-8210, pages 1 - 9, XP093254308 | |
| OPPOSITION | - Garnock-Jones Karly P., "Secukinumab: A Review in Moderate to Severe Plaque Psoriasis", American Journal of Clinical Dermatology, Springer Nature, (20150801), vol. 16, no. 4, doi:10.1007/s40257-015-0143-7, ISSN 1175-0561, pages 323 - 330, XP093281211 | |
| OPPOSITION | - Mease et al., "Managing Patients with Psoriatic Disease: The Diagnosis and Pharmacologic Treatment of Psoriatic Arthritis in Patients with Psoriasis", Drugs , (2014), vol. 74, doi:10.1007/s40265-014-0191-y, XP055411681 | |
| OPPOSITION | - Blair Hannah A., Dhillon Sohita, "Secukinumab: A Review in Ankylosing Spondylitis", Drugs, Adis International, Auckland, Auckland, (20160701), vol. 76, no. 10, doi:10.1007/s40265-016-0598-8, ISSN 0012-6667, pages 1023 - 1030, XP093281217 | |
| OPPOSITION | - Shirley Matt, Scott Lesley J., "Secukinumab: A Review in Psoriatic Arthritis", Drugs, Adis International, Auckland, Auckland, (20160701), vol. 76, no. 11, doi:10.1007/s40265-016-0602-3, ISSN 0012-6667, pages 1135 - 1145, XP093281215 | |
| OPPOSITION | - Saraceno, R. Griffiths, C.E.M., "A European perspective on the challenges of managing psoriasis", Journal of the American Academy of Dermatology, Elsevier Inc, United States, United States, (20060301), vol. 54, no. 3, doi:10.1016/j.jaad.2005.10.051, ISSN 0190-9622, pages S81 - S84, XP005292157 | |
| OPPOSITION | - Mrowietz Ulrich, Leonardi Craig L., Girolomoni Giampiero, Toth Darryl, Morita Akimichi, Balki Shyamal A., Szepietowski Jacek C., Regnault Pascaline, Thurston Helen, Papavassilis Charis, "Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: A randomized, double-blind, noninferiority trial (SCULPTURE)", Journal of the American Academy of Dermatology, Elsevier Inc, United States, United States, (20150701), vol. 73, no. 1, doi:10.1016/j.jaad.2015.04.011, ISSN 0190-9622, pages 27 - 36.e1, XP093281154 | |
| OPPOSITION | - Diamant Tha?i, Andrew Blauvelt, Kristian Reich, Tsen-Fang Tsai, Francisco Vanaclocha, K?lli Kingo, Michael Ziv, Andreas Pinter, Sophie Hugot, Ruquan You, Marina Milutinovic, "Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial", Journal of the American Academy of Dermatology, Elsevier Inc, United States, United States, (20150901), vol. 73, no. 3, doi:10.1016/j.jaad.2015.05.013, ISSN 0190-9622, pages 400 - 409, XP055387207 | |
| OPPOSITION | - GRIFFITHS CHRISTOPHER E M ET AL, "Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials", LANCET (NORTH AMERICAN EDITION), (20150801), vol. 386, no. 9993, doi:10.1016/S0140-6736(15)60125-8, pages 541 - 551, XP002774596 | |
| OPPOSITION | - Prinz Jc, "The role of T cells in psoriasis", JEADV , The Journal of the European Academy of Dermatology and Venereology, ELSEVIER SCIENCE PUBLISHERS, AMSTERDAM., NL, NL , (20030501), vol. 17, no. 3, doi:10.1046/j.1468-3083.2003.00720.x, ISSN 0926-9959, pages 257 - 270, XP093281146 | |
| OPPOSITION | - Richard G. Langley, Boni E. Elewski, Mark Lebwohl, Kristian Reich, Christopher E.M. Griffiths, Kim Papp, Lluís Puig, Hidemi Nakagawa, Lynda Spelman, Bárður Sigurgeirsson, Enrique Rivas, Tsen-Fang Tsai, Norman Wasel, Stephen Tyring, Thomas Salko, Isabelle Hampele, Marianne Notter, Alexander Karpov, Silvia Helou, Charis Papavassilis, "Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials", The New England journal of medicine, Massachusetts Medical Society, US, US , (20140724), vol. 371, no. 4, doi:10.1056/NEJMoa1314258, ISSN 0028-4793, pages 326 - 338, XP055414280 | |
| OPPOSITION | - A. Blauvelt; J.C. Prinz; A.B. Gottlieb; K. Kingo; H. Sofen; M. Ruer‐Mulard; V. Singh; R. Pathan; C. Papavassilis; S. Cooper, "Secukinumab administration by pre‐filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE)", British journal of dermatology (1951), Wiley, (20141211), vol. 172, no. 2, doi:10.1111/bjd.13348, ISSN 0007-0963, pages 484 - 493, XP071118535 | |
| OPPOSITION | - Strober Bruce; Sigurgeirsson Bárður; Popp Georg; Sinclair Rodney; Krell James; Stonkus Sigitas; Septe Marcis; Elewski Boni E; Gottlieb Alice B; Zhao Yang; Tran Mary H; Karpov Alexander; McLeod Lori D; Mordin Margaret; Papavassilis Charis; Nyirady Judit; Lebwohl Mark, "Secukinumab improves patient-reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo-controlled clinical trials.", INTERNATIONAL JOURNAL OF DERMATOLOGY MAR 2014, (20160331), vol. 55, no. 4, doi:10.1111/ijd.13236, ISSN 1365-4632, pages 401 - 407, XP009500505 | |
| OPPOSITION | - Mrowietz U., "Implementing treatment goals for successful long‐term management of psoriasis", JEADV , The Journal of the European Academy of Dermatology and Venereology, ELSEVIER SCIENCE PUBLISHERS, AMSTERDAM., NL, NL , (20120301), vol. 26, no. s2, doi:10.1111/j.1468-3083.2011.04411.x, ISSN 0926-9959, pages 12 - 20, XP093281160 | |
| OPPOSITION | - Paul C., Lacour J.‐p., Tedremets L., Kreutzer K., Jazayeri S., Adams S., Guindon C., You R., Papavassilis C., "Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE)", JEADV , The Journal of the European Academy of Dermatology and Venereology, ELSEVIER SCIENCE PUBLISHERS, AMSTERDAM., NL, NL , (20150601), vol. 29, no. 6, doi:10.1111/jdv.12751, ISSN 0926-9959, pages 1082 - 1090, XP093281235 | |
| OPPOSITION | - Alice B Gottlieb, B. Sigurgeirsson, A. Blauvelt, Y. Gong, C. Papavassilis, S. Mpofu, "AB0738 Secukinumab Reduces Hscrp Levels in Subjects with Moderate-To-Severe Plaque Psoriasis and Concomitant Psoriatic Arthritis: A Sub-Analysis from the Phase 3 Erasure Study", Annals of the Rheumatic Diseases, doi:10.1136/annrheumdis-2014-eular.1109, (20140101), pages 1 - 1, Annals of the Rheumatic Diseases, URL: http://ard.bmj.com/content/73/Suppl_2/1047.2.abstract, (20151111), XP055227757 | |
| OPPOSITION | - Cada Dennis J., Baker Danial E., Panther Shannon G., Pharmd Kyle Ingram, "Formulary Drug Reviews - Secukinumab", HOSPITAL PHARMACY., LIPPINCOTT, PHILADELPHIA., US, US , (20150901), vol. 50, no. 8, doi:10.1310/hpj5008-714, ISSN 0018-5787, pages 714 - 727, XP093281165 | |
| OPPOSITION | - Koenders Marije, Van Den Berg Wim, "Secukinumab for rheumatology: development and its potential place in therapy", Drug Design, Development and Therapy, Volume 10, doi:10.2147/DDDT.S105263, pages 2069 - 2080, XP093082027 | |
| OPPOSITION | - Girolomoni G., Griffiths C. E. M., Krueger J., Nestle F. O., Nicolas J-F., Prinz J. C., Puig L., Ståhle M., Van De Kerkhof P. C. M., Allez M., Emery P., Paul C., "Early intervention in psoriasis and immune-mediated inflammatory diseases: A hypothesis paper", Journal of Dermatological Treatment, (20150304), vol. 26, no. 2, doi:10.3109/09546634.2014.880396, ISSN 0954-6634, pages 103 - 112, XP093281156 | |
| OPPOSITION | - S. Cheuk, M. Wiken, L. Blomqvist, S. Nylen, T. Talme, M. Stahle, L. Eidsmo, "Epidermal Th22 and Tc17 Cells Form a Localized Disease Memory in Clinically Healed Psoriasis", Journal of Immunology, Williams & Wilkins Co., (20140401), vol. 192, no. 7, doi:10.4049/jimmunol.1302313, ISSN 0022-1767, pages 3111 - 3120, XP055414273 | |
