Table 1.
Antibody therapeutics granted first approvals in the European Union or the United States during 2018*.
| International non-proprietary name# | Brand name | Target; Format | Indication first approved | Date of first EU approval | Date of first US approval |
|---|---|---|---|---|---|
| Erenumab | Aimovig | CGRP receptor; Human IgG2 | Migraine prevention | 7/26/2018 | 5/17/2018 |
| Fremanezumab | Ajovy | CGRP; Humanized IgG2 | Migraine prevention | In review | 9/14/2018 |
| Galcanezumab | Emgality | CGRP; Humanized IgG4 | Migraine prevention | 11/14/2018 | 9/27/2018 |
| Burosumab | Crysvita | FGF23; Human IgG1 | X-linked hypophosphatemia | 2/19/2018 | 4/17/2018 |
| Lanadelumab | Takhzyro | Plasma kallikrein; Human IgG1 | Hereditary angioedema attacks | 11/22/2018 | 8/23/2018 |
| Caplacizumab | Cablivi | von Willebrand factor; Humanized Nanobody | Acquired thrombotic thrombocytopenic purpura | 8/31/2018 | In review |
| Mogamulizumab | Poteligeo | CCR4; Humanized IgG1 | Mycosis fungoides or Sézary syndrome | 11/22/2018 | 8/8/2018 |
| Moxetumomab pasudodox | Lumoxiti | CD22; Murine IgG1 dsFv immunotoxin | Hairy cell leukemia | NA | 9/13/2018 |
| Cemiplimab | Libtayo | PD-1; Human mAb | Cutaneous squamous cell carcinoma | In review | 9/28/2018 |
| Ibalizumab | Trogarzo | CD4; Humanized IgG4 | HIV infection | In review | 3/6/2018 |
| Tildrakizumab | Ilumetri, Ilumya | IL-23 p19; Humanized IgG1 | Plaque psoriasis | 9/17/2018 | 3/20/2018 |
| Emapalumab | Gamifant | IFNγ; Human IgG1 | Primary hemophagocytic lymphohistiocytosis | In review | 11/20/2018 |
Data available as of November 30, 2018. *Biosimilar products were excluded. #INN assigned by the World Health Organization; US product names in alphabetical order are burosomab-twza, cemiplimab-rwlc, emapalumab-lzsg, erenumab-aooe, fremanezumab-vfrm, galcanezumab-gnlm, ibalizumab-uiyk, lanadelumab-flyo, mogamulizumab-kpkc, moxetumomab pasudotox-tdfk, tildrakizumab-asmn. Abbreviations: CD, cluster of differentiation; CGRP, calcitonin gene-related peptide; dsFv, disulfide-stabilized variable fragment; EU European Union; FGF23, fibroblast growth factor 23; IgG, immunoglobulin G; NA, not applicable; PD-1 programmed cell death 1; US, United States.