References for First-In-Class Agents and Pharmacological Similars

Part 1: First-In-Class Agents and Part 2: Pharmacological Similars
1. +
Blumenthal  DK. Chapter 3. Pharmacodynamics: Molecular Mechanisms of Drug Action. In: Brunton  LL, Hilal-Dandan  R, Knollmann  BC. eds. Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 13e. New York, NY: McGraw-Hill; 2018. Available from McGraw Hill Education. accessmedicine.mhmedical.com/content.aspx?bookid=2189&sectionid=170349571 (accessed Feb. 27, 2019).
2. +
Yan  L, Zhang  W. Precision medicine becomes reality-tumor type-agnostic therapy. Cancer Commun (Lond). 2018;38(1):6.
[PubMed: 29764494] ; PubMed Central PMCID: PMC5953403.
3. +
ABLYSINOL (dehydrated alcohol) injection, for cardiac septal branch intra-arterial use [product information]. Revised: 6/2018. Belcher Pharmaceuticals, LLC, Largo, FL. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/207987lbl.pdf (accessed Feb. 27, 2019).
4. +
Food and Drug Administration Center for Drug Evaluation and Research: NDA 207987 [APPROVAL Letter]. Dated 06/21/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207987Orig1s000ltr.pdf (accessed Feb. 27, 2019).
5. +
Azedra® (iobenguane I 131) injection, for intravenous use [product information]. Revised: 7/2018. Progenics Pharmaceuticals, Inc.; New York, NY. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/209607s000lbl.pdf (accessed Feb. 27, 2019).
6. +
FDA approves first treatment for rare adrenal tumors [FDA News Release]. July 30, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615155.htm (accessed Jan. 5, 2019).
7. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves iobenguane I 131 for rare adrenal gland tumors [webpage]. Last Updated: 07/30/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm615157.htm (accessed Jan. 3, 2019).
8. +
Lutathera® (lutetium Lu 177 dotatate) injection, for intravenous use [product information]. Revised: 01/2018. Advanced Accelerator Applications USA, Inc., NJ. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/208700s000lbl.pdf (accessed Jan. 1, 2019).
9. +
FDA approves new treatment for certain digestive tract cancers [FDA News Release]. January 26, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594043.htm (accessed Jan. 1, 2019).
10. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves lutetium Lu 177 dotatate for treatment of GEP-NETS [webpage]. Last Updated: 01/26/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm594105.htm (accessed Jan. 3, 2019).
11. +
Drug Trials Snapshot: Lutathera [webpage]. Last Updated: 02/20/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm597090.htm (accessed Jan. 1, 2019).
12. +
Primatene Mist (epinephrine) 0.125 mg/inhalation [OTC Drug Facts label]. Armstrong Pharms. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205920 (accessed Feb. 27, 2019).
13. +
Epinephrine CFC Metered-dose Inhalers—Questions and Answers [webpage]. Last Updated: 02/22/2016 Available from: U.S. Department of Health and Human Services, Food and Drug Administration. https://wayback.archive-it.org/7993/20170723104117/https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm080427.htm (accessed Feb. 28, 2019).
14. +
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma [FDA News Release]. November 8, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625338.htm (accessed Feb. 4, 2019).
15. +
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections [FDA News Release]. June 12, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610503.htm (accessed Jan. 5, 2019).
16. +
CY 2018 CDER Breakthrough Therapy Calendar Year Approvals: Data as of December 31, 2018 [webpage]. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/drugandbiologicapprovalreports/ndaandblaapprovalreports/ucm494010.pdf (accessed Feb. 21, 2019).
17. +
Food and Drug Administration Safety and Innovation Act (FDASIA)—Fact Sheet: Breakthrough Therapies [webpage]. Last Updated: 3/28/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm (accessed Feb 21, 2019).
18. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: 2018 Cancer Approvals [webpage]. Last Updated: 2/26/2019. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/drugs/informationondrugs/approveddrugs/ucm279174.htm (accessed Feb 27, 2019)
19. +
FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation [FDA News Release]. September 28, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622048.htm (accessed Feb. 21, 2019).
20. +
Safety Announcement: FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod) [webpage]. Last Updated: 12/20/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/DrugSafety/ucm626095.htm (accessed Feb. 27, 2019).
21. +
Orphan Drug Product designation database: Search Orphan Drug Designations and Approvals [webpage]. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/ (accessed Feb. 27, 2019).
22. +
Noshi  T, Kitano  M, Taniguchi  K,  et al. In vitro characterization of baloxavir acid, a first-in-class cap-dependent endonuclease inhibitor of the influenza virus polymerase PA subunit. Antiviral Res. 2018;160:109–117.
[PubMed: 30316915] .
23. +
FDA approves the first drug with an indication for treatment of smallpox [FDA News Release]. July 13, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613496.htm (accessed Feb. 3, 2019).
24. +
DrugBank: Stiripentol (Accession number = DB09118) [open database]. Available from: Wishart Research Group. University of Alberta; Edmonton, Canada. www.drugbank.ca/drugs/DB09118 (accessed Feb. 3, 2019).
25. +
Guce  AI, Clark  NE, Rogich  JJ,  et al. The molecular basis of pharmacological chaperoning in human α-galactosidase. Chem Biol. 2011;18(12):1521–1526.
[PubMed: 22195554] ; PubMed Central PMCID: PMC3246215.
26. +
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation [FDA News Release]. July 20, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614115.htm (accessed Jan. 1, 2019).
27. +
McAdoo  SP, Tam  FW. Fostamatinib disodium. Drugs Future. 2011;36(4):273.
[PubMed: 23284223] ; PubMed Central PMCID: PMC3533134.
28. +
Blumenthal  GM, Pazdur  R. Supplementary Table 1 - Summary of FDA oncology drug approvals in 2018 (in decreasing chronological order). Supplementary Information to: Blumenthal  GM, Pazdur  R. Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review. Nat Rev Clin Oncol. 2019;16(3):139–141.
[PubMed: 30670830] . Available from Nature Publishing Group. https://static-content.springer.com/esm/art%3A10.1038%2Fs41571-019-0170-z/MediaObjects/41571_2019_170_MOESM1_ESM.pdf (accessed Feb. 27, 2019).
29. +
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency [FDA News Release]. July 18, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613801.htm (accessed Jan. 5, 2019).
30. +
Oncology Center of Excellence: Real-Time Oncology Review Pilot Program [webpage]. Last Updated: 01/29/2019. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm (accessed Feb. 21, 2019).
31. +
Morrison  C. Fresh from the biotech pipeline-2018. Nat Biotechnol. 2019;37(2) :118–123.
[PubMed: 30718867] .
32. +
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot [FDA News Release]. November 16, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626079.htm (accessed Feb. 21, 2019).
33. +
Approved Drugs: FDA grants regular approval for pembrolizumab in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC [webpage]. Last Updated: 08/20/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617471.htm (accessed Feb. 21, 2018).
34. +
List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) [webpage]. Last Updated: 12/13/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm (accessed Feb. 21, 2019).
35. +
Companion Diagnostics [webpage]. Last Updated: 12/07/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407297.htm (accessed Feb 21, 2019).
36. +
Approved Drugs: FDA updates prescribing information for Keytruda and Tecentriq [webpage]. Last Updated: 08/20/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617378.htm (accessed Feb 21, 2019).
37. +
Approved Drugs: FDA limits the use of Tecentriq and Keytruda for some urothelial cancer patients [webpage]. Last Updated: 07/05/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm612484.htm (accessed Feb. 21, 2019).
38. +
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products [FDA News Release]. December 6, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627745.htm (accessed Jan. 4, 2019).
39. +
Ju  H, Zhang  J, Huang  B,  et al. Inhibitors of Influenza Virus Polymerase Acidic (PA) Endonuclease: Contemporary Developments and Perspectives. J Med Chem. 2017;60(9):3533–3551.
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40. +
XOFLUZATM (baloxavir marboxil) tablets for oral use[product information]. Revised: 10/2018. Genentech USA, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/210854s000lbl.pdf (accessed 1/1/2019).
41. +
Drug Trials Snapshot: XOFLUZA [webpage]. Last Updated: 11/06/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm624981.htm (accessed 1/1/2019).
42. +
Ma  TK, McAdoo  SP, Tam  FW. Spleen tyrosine kinase: A crucial player and potential therapeutic target in renal disease. Nephron. 2016;133(4):261–269.
[PubMed: 27476075] .
43. +
TAVALISSETM (fostamatinib disodium hexahydrate) tablets for oral use [product information]. Revised: 04/2018. Rigel Pharmaceuticals, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/209299lbl.pdf (accessed 1/1/2019).
44. +
Tegsedi (inotersen) injection, for subcutaneous use [product information]. Revised: 10/2018. Ionis Pharmaceuticals, Inc.; Carlsbad, CA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/211172lbl.pdf (accessed 1/1/2019).
45. +
ONPATTRO (patisiran) lipid complex injection, for intravenous use [product information]. Revised: 8/2018. Alnylam Pharmaceuticals, Inc.; Cambridge, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/210922s000lbl.pdf (accessed 1/1/2019).
46. +
Dhillon  S. Ivosidenib: First Global Approval. Drugs. 2018;78(14):1509–1516. Erratum in: Drugs. 2019;79(1):107.
[PubMed: 30209701] ; PubMed Central PMCID: PMC6315051.
47. +
Tibsovo® (ivosidenib tablets) for oral use [product information]. Revised: 07/2018. Agios Pharmaceuticals, Inc.; Cambridge, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf (accessed 1/1/2019).
48. +
Lange  AM, Lo  HW. Inhibiting TRK proteins in clinical cancer therapy. Cancers (Basel). 2018;10(4):E105.
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49. +
Vitrakvi® (larotrectinib) capsules for oral use and oral solution [product information]. Revised: 11/2018. Loxo Oncology, Inc.; Stamford, CT. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/210861s000lbl.pdf (accessed 1/1/2019).
50. +
GalafoldTM (migalastat) capsules for oral use [product information]. Revised: 08/2018. Amicus Therapeutics U.S., Inc.; Cranbury, NJ. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/208623lbl.pdf (accessed 1/1/2019).
51. +
Diacomit (stiripentol) capsules for oral use and powder for oral suspension [product information]. Revised: 8/2018. Biocodex; Beauvais—France. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf (accessed 1/1/2019).
52. +
Tpoxx (tecovirimat) capsules for oral use [product information]. Revised: 07/2018. SIGA Technologies, Inc.; Corvallis, OR. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/208627s000lbl.pdf (accessed 1/1/2019).
53. +
Preissner  S, Kroll  K, Dunkel  M,  et al. SuperCYP: a comprehensive database on Cytochrome P450 enzymes including a tool for analysis of CYP-drug interactions. Nucleic Acids Res. 2010;38:D237–D243.
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54. +
FDA approves new drug to treat influenza [FDA News Release]. October 24, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624226.htm (accessed 1/1/2019).
55. +
Flu News & Spotlights: CDC Responds to Approval of New Flu Antiviral Drug [webpage]. Last updated: December 4, 2018. Available from: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. www.cdc.gov/flu/spotlights/cdc-responds-approval-new-flu-drug.htm (accessed Feb. 2, 2019).
56. +
Influenza Antiviral Medications: Summary for Clinicians [webpage]. Last updated: December 27, 2018. Available from: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm (accessed Feb. 2, 2019).
57. +
Mushtaq  A. Baloxavir: game-changer or much ado about nothing? Lancet Respir Med. 2018;6(12):903–904.
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58. +
Uyeki  TM. A step forward in the treatment of influenza. N Engl J Med. 2018;379(10):975–977.
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59. +
Kikuchi  T, Watanabe  A. Baloxavir heralds a new era in influenza virus biology. Respir Investig. 2019;57(1):1–2.
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60. +
Flu Activity & Surveillance: Fluview [webpage]. Last updated: August 23, 2018]. Available from: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. www.cdc.gov/flu/weekly/fluactivitysurv.htm (accessed Feb. 2, 2019).
61. +
Heo  YA. Baloxavir: First global approval. Drugs. 2018;78(6):693–697.
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62. +
Watanabe  A, Ishida  T, Hirotsu  N,  et al. Baloxavir marboxil in Japanese patients with seasonal influenza: Dose response and virus type/subtype outcomes from a randomized phase 2 study. Antiviral Res. 2019;163:75–81.
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63. +
Hayden  FG, Sugaya  N, Hirotsu  N,  et al: Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018;379(10):913–923.
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64. +
Mossad  SB. Influenza update 2018-2019: 100 years after the great pandemic. Cleve Clin J Med. 2018;85(11):861–869.
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65. +
Hawkes  N. Sixty seconds on…baloxavir. BMJ. 2018;363:k4531.
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66. +
National Center for Biotechnology Information. PubChem Compound Database. Baloxavir Marboxil: CID=124081896. https://pubchem.ncbi.nlm.nih.gov/compound/124081896 (accessed Feb. 2, 2019).
67. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves fostamatinib tablets for ITP [webpage]. Last updated: 04/18/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604956.htm (accessed Jan. 3, 2019).
68. +
Markham  A. Fostamatinib: First global approval. Drugs. 2018;78(9):959–963.
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69. +
McKeage  K, Lyseng-Williamson  KA. Fostamatinib in chronic immune thrombocytopenia: a profile of its use in the USA. Drugs Ther Perspect. 2018;34(10):451–456.
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70. +
Newland  A, Lee  EJ, McDonald  V, Bussel  JB. Fostamatinib for persistent/chronic adult immune thrombocytopenia. Immunotherapy. 2018;10(1):9–25.
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71. +
DrugBank: Fostamatinib (Accession number: DB12010) [open database]. Available from: Wishart Research Group. University of Alberta; Edmonton, Canada. www.drugbank.ca/drugs/DB12010 (accessed Feb. 2, 2019).
72. +
Drug Profile: Fostamatinib - Rigel Pharmaceuticals. AdisInsight Drugs [database]. Released 2005 January 13, Updated 2019 January 28. Available from: Springer Nature Switzerland AG. http://adisinsight.springer.com/drugs/800021937 (accessed Jan. 29, 2019).
73. +
Drug Trials Snapshot: Tavalisse [webpage]. Last Updated: 04/25/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm605411.htm (accessed Mar. 1, 2019).
74. +
National Center for Biotechnology Information. PubChem Compound Database. Fostamatinib disodium hexahydrate: CID=24828759. https://pubchem.ncbi.nlm.nih.gov/compound/24828759 (accessed Feb. 2, 2019).
75. +
FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease [FDA News Release]. August 10, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616518.htm (accessed 1/1/2019).
76. +
Rizk  M, Tüzmen  Ş. Update on the clinical utility of an RNA interference-based treatment: focus on Patisiran. Pharmgenomics Pers Med. 2017;10:267–278.
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77. +
Benson  MD, Waddington-Cruz  M, Berk  JL,  et al. Inotersen treatment for patients with hereditary transthyretin amyloidosis. N Engl J Med. 2018;379(1):22–31.
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78. +
Kristen  AV, Ajroud-Driss  S, Conceição  I,  et al. Patisiran, an RNAi therapeutic for the treatment of hereditary transthyretin-mediated amyloidosis. Neurodegener Dis Manag. 2019;9(1):5–23.
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79. +
Hoy  SM. Patisiran: First global approval. Drugs. 2018;78(15):1625–1631.
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80. +
Keam  SJ. Inotersen: First global approval. Drugs. 2018;78(13):1371–1376.
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81. +
Adams  D, Gonzalez-Duarte  A, O'Riordan  WD,  et al. Patisiran, an RNAi therapeutic, for hereditary transthyretin amyloidosis. N Engl J Med. 2018;379(1):11–21.
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82. +
Armstrong,  M. Tegsedi gets US green light, but still looks second best. Vantage October 8, 2018. Copyright 2019 Evaluate Ltd. http://www.evaluate.com/vantage/articles/news/snippets/tegsedi-gets-us-green-light-still-looks-second-best (accessed Feb. 28, 2019).
83. +
Approved Risk Evaluation and Mitigation Strategies (REMS): Tegsedi (Inotersen) NDA #211172 [webpage]. REMS last update: 10/05/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/Scripts/Cder/Rems/index.cfm?event=IndvRemsDetails.page&REMS=383 (accessed Feb. 28, 2019).
84. +
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85. +
Bennett  CF, Baker  BF, Pham  N,  et al. Pharmacology of antisense drugs. Annu Rev Pharmacol Toxicol. 2017;57:81–105.
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86. +
Titze-de-Almeida  R, David  C, Titze-de-Almeida  SS. The race of 10 synthetic RNAi-based drugs to the pharmaceutical market. Pharm Res. 2017;34(7):1339–1363. Erratum in: Pharm Res. 2018;35(3):53.
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87. +
DrugBank [open database, version 5.1.2]: Patisiran (Accession number = DB14582). Available from: Wishart Research Group. University of Alberta; Edmonton, Canada. www.drugbank.ca/drugs/DB14582 (accessed Feb. 2, 2019).
88. +
National Center for Biotechnology Information. PubChem Compound Database. Patisiran: SID=350082694. https://pubchem.ncbi.nlm.nih.gov/substance/350082694 (accessed Feb. 2, 2019).
89. +
Dhillon  S. Ivosidenib: First global approval. Drugs. 2018;78(14):1509–1516. Erratum in: Drugs. 2019;79(1):107.
[PubMed: 30209701] ; PubMed Central PMCID: PMC6315051.
90. +
Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves ivosidenib for relapsed or refractory acute myeloid leukemia [webpage]. Last updated: 10/18/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm614128.htm (accessed Jan. 3, 2019).
91. +
DrugBank [open database, version 5.1.2]: Ivosidenib (Accession number = DB14568). Available from: Wishart Research Group. University of Alberta; Edmonton, Canada. www.drugbank.ca/drugs/DB14568 (accessed Feb. 2, 2019).
92. +
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94. +
Drug Trials Snapshot: Tibsovo [webpage]. Last Updated: 08/02/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm615501.htm (accessed Mar. 1, 2019).
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