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| OPPOSITION | - Alfred Goodman Gilman; Grant R. Wilkinson, "SECTION I: GENERAL PRINCIPLES: Introduction; Chapter 1. Pharmacokinetics: The Dynamics of Drug Absorption, Distribution, and Elimination", Alfred Goodman Gilman; Grant R. Wilkinson, Joel G. Hardman (ed.), Goodman and Gilman’s The Pharmacological Basis of Therapeutics, McGraw Hill , (20010101), pages 3 - 29, ISBN 0-07-112432-2, XP009527304 | - |
| OPPOSITION | - Anonymous, "NUCALA (mepolizumab) for injection, for subcutaneous use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20151101), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526orig1s000lbl.pdf, XP093309552 | - |
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| OPPOSITION | - D10 - Submission of the applicant during examination of 28.09.2023 | - |
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| OPPOSITION | - D1 - Expert declaration bv Prof Nathwani | - |
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| OPPOSITION | - D9 - Press release by Chugai Jul 28, 2016 "Chugai's Emicizumab Showed Continued Benefits in Patients with Hemophilia A-Update from Japanese P 1/11 study presented at WFH 2016" https://www.chugaioharm.co.io/enqlish/news/detail/20160728113000129.html | - |
| OPPOSITION | - Hoffmann-La Roche, "A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors (HAVEN 3) - NCT02847637", Clinical Trials, clinicaltrials.gov, (20160901), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02847637?term=NCT02847637&rank=1&tab=history&a=3#version-content-panel, XP093309497 | - |
| OPPOSITION | - Hoffmann-La Roche, "A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors (HAVEN 2) - NCT02795767 ", Clinical Trials, clinicaltrials.gov, (20160701), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02795767?term=NCT02795767&rank=1&tab=history&a=2#version-content-panel, XP093309496 | - |
| OPPOSITION | - Hoffmann-La Roche, "A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors (HAVEN 1) - NCT02622321", Clinical Trials, clinicaltrials.gov, (20160810), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02622321?term=%20NCT02622321%20&rank=1&tab=history&a=10#version-content-panel, XP093309494 | - |
| OPPOSITION | - Hoffmann-La Roche, "A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks in Participants With Hemophilia A (HAVEN 4) - NCT03020160", Clinical Trials, clinicaltrials.gov, (20170331), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT03020160?term=NCT03020160&rank=1&tab=history&a=4#version-content-panel, XP093309500 | - |
| OPPOSITION | - John H. Collett, Soraya Dhillon, "DOSAGE REGIMENS", Aulton's Pharmaceutics: The Design and Manufacture of Medicines Fourth edition, Elsevier Ltd., (20130101), pages 2pp, 355 - 366, XP055794776 | - |
| OPPOSITION | - Paul Rolan, "Chapter 5: Clinical Pharmacokinetics", Paul Rolan, Griffin, J.P., O’Grady, J., The Textbook of Pharmaceutical Medicine, 4th ed., BMJ Books, (20020101), pages 214 - 246, ISBN 0-7279-1523-1, XP009562783 | - |
| OPPOSITION | - William K. Plunkett Jr. Mark Ratain, "Chapter 47 : Pharmacology", Holland-Frei Cancer Medicine, 8th edition, PEOPLE’S MEDICAL PUBLISHING HOUSE-USA, (20100101), pages 587 - 596, ISBN 978-1-60795-014-1, XP009562782 | - |
| OPPOSITION | - Yoneyama K., C. Schmitt, N. Kotani, N. Fukazawa, G. G. Levy, S. Iida, M. Shima, T. Kawanishi, "PI-003REPEATED TIME-TO-EVENT MODELING TO CHARACTERIZE THE BLEEDING-PROPHYLACTIC EFFICACY OF ACE910, A BISPECIFIC ANTIBODY TO FACTORS IXA AND X, IN PATIENTS WITH HEMOPHILIA A", American Society for Clinical Pharmacology and Therapeutics, Abstracts of papers, (20160201), vol. 99, no. S1, XP093309556 | - |
| OPPOSITION | - Othman Ahmed A., Jonathan Q. Tran, Meina T. Tang, Sandeep Dutta, "POPULATION PHARMACOKINETICS OF DACLIZUMAB HIGH-YIELD PROCESS IN HEALTHY VOLUNTEERS: INTEGRATED ANALYSIS OF INTRAVENOUS AND SUBCUTANEOUS, SINGLE- AND MULTIPLE-DOSE ADMINISTRATION", CLINICAL PHARMACOKINETICS, doi:10.1007/s40262-014-0159-9, XP093309560 | |
| OPPOSITION | - Retout Sylvie, Retout Sylvie, Schmitt Christophe, Petry Claire, Mercier François, Frey Nicolas, "Population Pharmacokinetic Analysis and Exploratory Exposure-Bleeding Rate Relationship of Emicizumab in Adult and Pediatric Persons with Hemophilia A", CLINICAL PHARMACOKINETICS., ADIS INTERNATIONAL LTD., AUCKLAND, NZ, NZ , (20200605), vol. 59, no. 12, doi:10.1007/s40262-020-00904-z, ISSN 0312-5963, pages 1611 - 1625, XP055817453 | |
| OPPOSITION | - Nogami Keiji, "Bispecific antibody mimicking factor VIII", THROMBOSIS RESEARCH, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (19000101), vol. 141, doi:10.1016/S0049-3848(16)30361-9, ISSN 0049-3848, XP029541330 | |
| OPPOSITION | - Pipe Steven W, Shima Midori, Lehle Michaela, Shapiro Amy, Chebon Sammy, Fukutake Katsuyuki, Key Nigel S, Portron Agnès, Schmitt Christophe, Podolak-Dawidziak Maria, Selak Bienz Nives, Hermans Cedric, Campinha-Bacote Avrita, Kiialainen Anna, Peerlinck Kathelijne, Levy Gallia G, Jiménez-Yuste Victor, "Efficacy, safety, and pharmacokinetics of emicizumab prophylaxis given every 4 weeks in people with haemophilia A (HAVEN 4): a multicentre, open-label, non-randomised phase 3 study", Lancet Haematology, Elsevier, (20190601), vol. 6, no. 6, doi:10.1016/S2352-3026(19)30054-7, ISSN 2352-3026, pages e295 - e305, XP093309526 | |
| OPPOSITION | - Dimichele Donna, "Hemophilia Therapy- Navigating Speed Bumps on the Innovation Highway ", N Engl J Med, (20160526), vol. 374, no. 21, doi:10.1056/NEJMel603504, pages 2087 - 2089, XP093309524 | |
| OPPOSITION | - Midori Shima, Hideji Hanabusa, Masashi Taki, Tadashi Matsushita, Tetsuji Sato, Katsuyuki Fukutake, Naoki Fukazawa, Koichiro Yoneyama, Hiroki Yoshida, Keiji Nogami, "Factor VIII-Mimetic Function of Humanized Bispecific Antibody in Hemophilia A", The new England journal of medicine, Eli Lily and Company, USA, USA, (20160526), vol. 374, no. 21, doi:10.1056/NEJMoa1511769, pages 2044 - 2053, XP055686042 | |
| OPPOSITION | - Johannes Oldenburg, Mahlangu Johnny N., Kim Benjamin, Schmitt Christophe, Callaghan Michael U., Young Guy, Santagostino Elena, Kruse-Jarres Rebecca, Negrier Claude, Kessler Craig, Valente Nancy, Asikanius Elina, Levy Gallia G., Windyga Jerzy, Shima Midori, "Emicizumab Prophylaxis in Hemophilia A with Inhibitors", The new England journal of medicine, Eli Lily and Company, USA, USA, (20170831), vol. 377, no. 9, doi:10.1056/NEJMoa1703068, pages 809 - 818, XP055686025 | |
| OPPOSITION | - Johnny Mahlangu, Johannes Oldenburg, Ido Paz-Priel, Claude Negrier, Markus Niggli, M. Elisa Mancuso, Christophe Schmitt, Victor Jiménez-Yuste, Christine Kempton, Christophe Dhalluin, Michael U. Callaghan, Willem Bujan, Midori Shima, Joanne I. Adamkewicz, Elina Asikanius, Gallia G. Levy, Rebecca Kruse-Jarres, "Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors", The new England journal of medicine, Eli Lily and Company, USA, USA, (20180830), vol. 379, no. 9, doi:10.1056/NEJMoa1803550, pages 811 - 822, XP055686026 | |
| OPPOSITION | - I. E. M. Den Uijl, K. Fischer, J. G. Van Der Bom, D. E. Grobbee, F. R. Rosendaal, I. Plug, "Analysis of low frequency bleeding data: the association of joint bleeds according to baseline FVIII activity levels : ANALYSIS OF BLEEDING DATA IN HAEMOPHILIA", HAEMOPHILIA, BLACKWELL SCIENCE, OXFORD, GB, GB , (20110101), vol. 17, no. 1, doi:10.1111/j.1365-2516.2010.02383.x, ISSN 1351-8216, pages 41 - 44, XP055697365 | |
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| OPPOSITION | - A. Muto, W A, W A, R A, B E, M, O R, Muto A, Yoshihashi K, Takeda M, Kitazawa T, Soeda T, Igawa T, Sakamoto Y, Haraya K, Kawabe Y, Shima M, Yoshioka A, Hattori K Anti, "Anti-factor IXa/X bispecific antibody (ACE910): hemostatic potency against ongoing bleeds in a hemophilia A model and the possibility of routine supplementation", JOURNAL OF THROMBOSIS AND HAEMOSTASIS, BLACKWELL PUBLISHING, OXFORD, GB, GB , (20140201), vol. 12, no. 2, doi:10.1111/jth.12474, ISSN 1538-7933, pages 206 - 213, XP055214235 | |
| OPPOSITION | - Blanchette V.S., Key N.S., Ljung L.R., Manco‐johnson M.J., Van Den Berg H.M., Srivastava A., "Definitions in hemophilia: communication from the SSC of the ISTH", Journal of thrombosis and haemostasis, John Wiley & Sons, (20141101), vol. 12, no. 11, doi:10.1111/jth.12672, ISSN 1538-7836, pages 1935 - 1939, XP093309502 | |
| OPPOSITION | - Shima M, Hanabusa H, Taki M, Matsushita T, Sato T, Fukutake K, Fukazawa N, Yoneyama K, Yoshida H, Takahashi H, Nogami K, "AS017: Long-term safety and prophylactic efficacy of once-weekly subcutaneous administration of ACE910 , in Japanese hemophilia A patients with and without FVIII inhibitors: interim results of the extension study of a phase 1 study", JOURNAL OF THROMBOSIS AND HAEMOSTASIS, BLACKWELL PUBLISHING, OXFORD, GB, GB , (20150101), vol. 13, no. Suppl. 2, doi:10.1111/jth.12993, ISSN 1538-7933, pages 6 - 7, XP009513701 | |
| OPPOSITION | - P. E. Monahan, Harold R Roberts, Comprehensive Hemophilia, "Emerging genetic and pharmacologic therapies for controlling hemostasis: beyond recombinant clotting factors", American society of hematology, American society of hematology, Washington, DC, US, US , (20151201), vol. 2015, no. 1, doi:10.1182/asheducation-2015.1.33, ISSN 1520-4391, pages 33 - 40, XP055344972 | |
| OPPOSITION | - Atsushi Muto, Yoshihashi Kazutaka, Takeda Minako, Kitazawa Takehisa, Soeda Tetsuhiro, Igawa Tomoyuki, Sampei Zenjiro, Kuramochi Taichi, Sakamoto Akihisa, Haraya Kenta, Adachi Kenji, Kawabe Yoshiki, Nogami Keiji, Shima Midori, Hattori Kunihiro, "Anti-factor IXa/X bispecific antibody ACE910 prevents joint bleeds in a long-term primate model of acquired hemophilia A", blood, doi:10.1182/blood-2014-07-585737, (20141101), pages 3165 - 3171, blood, (20160125), XP055244233 | |
| OPPOSITION | - Naoki Uchida, Sambe Takehiko, Yoneyama Koichiro, Fukazawa Naoki, Kawanishi Takehiko, Kobayashi Shinichi, Shima Midori, " A first-in-human phase 1 study of ACE910, a novel factor VIII–mimetic bispecific antibody, in healthy subjects", blood, (20160331), vol. 127, doi:10.1182/blood-2015-06-, pages 1633 - 1641, XP055442821 | |
| OPPOSITION | - Makris Michael, "Hemophilia A treatment: disruptive technology ahead", Blood, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20160331), vol. 127, no. 13, doi:10.1182/blood-2016-01-691469, ISSN 0006-4971, pages 1623 - 1624, XP093309520 | |
| OPPOSITION | - Zenjiro Sampei, Igawa Tomoyuki, Soeda Tetsuhiro, Okuyama Nishida Yukiko, Moriyama Chifumi, Wakabayashi Tetsuya, Tanaka Eriko, Muto Atsushi, Kojima Tetsuo, Kitazawa Takehisa, Yoshihashi Kazutaka, Harada Aya, Funaki Miho, Haraya Kenta, Tachibana Tatsuhiko, Suzuki Sachiyo, Esaki Keiko, Nabuchi Yoshiaki, Hattori Kunihiro, Lenting Peter, "Identification and Multidimensional Optimization of an Asymmetric Bispecific IgG Antibody Mimicking the Function of Factor VIII Cofactor Activity", PLOS ONE, Public Library of Science, US, US , (20130201), vol. 8, no. 2, doi:10.1371/journal.pone.0057479, ISSN 1932-6203, pages 1 - 13, XP055127871 | |
| OPPOSITION | - Franchini Massimo, "Next-generation treatment of acquired hemophilia A", Expert Opinion on Orphan Drugs, Informa Healthcare, UK, UK , (20150304), vol. 3, no. 3, doi:10.1517/21678707.2015.1017470, ISSN 2167-8707, pages 245 - 251, XP093309505 | |
| SEARCH | - MIDORI SHIMA ET AL, "Factor VIII-Mimetic Function of Humanized Bispecific Antibody in Hemophilia A", THE NEW ENGLAND JOURNAL OF MEDICINE, - NEJM -, US, (20160526), vol. 374, no. 21, doi:10.1056/NEJMoa1511769, ISSN 0028-4793, pages 2044 - 2053, XP055686042 [Y] 1-15 * page 2046, column left, paragraph 3 * * abstract * * page 2052, column r, paragraph final * | |
| SEARCH | - JOHANNES OLDENBURG ET AL, "Emicizumab Prophylaxis in Hemophilia A with Inhibitors", THE NEW ENGLAND JOURNAL OF MEDICINE, - NEJM -, US, (20170815), vol. 377, no. 9, doi:10.1056/NEJMoa1703068, ISSN 0028-4793, pages 809 - 818, XP055686025 [YP] 1-15 * the whole document * | |
| SEARCH | - JOHNNY MAHLANGU ET AL, "Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors", THE NEW ENGLAND JOURNAL OF MEDICINE, - NEJM -, US, (20180830), vol. 379, no. 9, doi:10.1056/NEJMoa1803550, ISSN 0028-4793, pages 811 - 822, XP055686026 [T] 1-15 | |
