Antibody Societyサイトの紹介
抗体医薬の承認数は増加するばかりです。バイオシミラー(Biosimilar)以外の新薬に関する承認済みやレビュー中のリストは、「Antibody Society」のサイトで見ることができます。
- 以降に示したテーブルは2020/5現在のEU/USでの承認済み抗体医薬のリストです。
- 2021/01~2021/09までに、9つの抗体医薬が承認され(リンクから確認)、2021/10現在、21つの抗体医薬の開発が規制当局に登録されています。
抗体協会は、承認された抗体治療薬と欧州連合(EU)または米国(米国)で規制審査中のものの包括的なリストを維持しています。 下の表では、レビュー中の製品候補が最初にリストされ、承認された製品は最初の承認の年ごとに新しい順にリストされています。 承認されたが、その後市場から撤退した製品は、表に含まれています。 バイオシミラー製品は除きます。 欧州医薬品庁(EMA)が公開している人間の医薬品に関するヨーロッパの公開評価レポート、および保留中の欧州委員会の決定と評価中の医薬品に関する情報は、EMAの[Find medicine]ページで確認できます。 米国で承認された治療法に関する情報は、Drugs @ FDAにあります。 EUまたは米国以外の地域で最初の承認が与えられた抗体療法は、表の最後に記載されています。 5月1日の時点で、2020年に米国で4つの抗体治療薬が初めて承認され、さらに15件が規制当局による審査を受けています。
Antibody Society
欧州または米国で承認済みまたは審査中の治療用モノクローナル抗体(Therapeutic monoclonal antibodies approved or in review in the EU or US.)
international non-profit supporting antibody-related research and development
https://www.antibodysociety.org/resources/approved-antibodies/
以下は、2020/05/01時点のリストです。最新は、リンクから確認ください。
INN | Brand name | Target; Format | 1st indication approved / reviewed | 1st EU approval year | 1st US approval year |
Sutimlimab | (Pending) | C1s; Humanized IgG4 | Cold agglutinin disease | NA | Review |
Aducanumab | (Pending) | Amyloid beta; Human IgG1 | Alzheimer’s disease | NA | Review |
Teplizumab | (Pending) | CD3; Humanized IgG1 | Type 1 diabetes | NA | Review |
Dostarlimab | (Pending) | PD-1; Humanized IgG4 | Endometrial cancer | Review | Review |
Tanezumab | (Pending) | Nerve growth factor; Humanized IgG2 | Osteoarthritis pain | Review | Review |
Margetuximab | (Pending) | HER2; Chimeric IgG1 | HER2+ breast cancer | NA | Review |
Naxitamab | (Pending) | GD2; Humanized IgG1 | High-risk neuroblastoma and refractory osteomedullary disease | NA | Review |
Belantamab mafodotin | (Pending) | BCMA; Humanized IgG1 ADC | Multiple myeloma | Review | Review |
Oportuzumab monatox | (Pending) | EpCAM; Humanized scFv immunotoxin | Bladder cancer | NA | Review |
REGNEB3 | (Pending) | Ebola virus; mixture of 3 human IgG1 | Ebola virus infection | NA | Review |
Narsoplimab | (Pending) | MASP-2; Human IgG4 | Hematopoietic stem cell transplant-associated thrombotic microangiopathies | NA | Review |
Tafasitamab | (Pending) | CD19; Humanized IgG1 | Diffuse large B-cell lymphoma | NA | Review |
Satralizumab | (Pending) | IL-6R; Humanized IgG2 | Neuromyelitis optica and neuromyelitis optica spectrum disorders | Review | Review |
Inebilizumab | (Pending) | CD19; Humanized IgG1 | Neuromyelitis optica and neuromyelitis optica spectrum disorders | NA | Review |
Leronlimab | (Pending) | CCR5; Humanized IgG4 | HIV infection | NA | Review |
Sacituzumab govitecan | Trodelvy | TROP-2; Humanized IgG1 ADC | Triple-neg. breast cancer | NA | 2020 |
Teprotumumab | Tepezza | IGF-1R; Human IgG1 | Thyroid eye disease | NA | 2020 |
Isatuximab | Sarclisa | CD38; Chimeric IgG1 | Multiple myeloma | Review | 2020 |
Eptinezumab | Vyepti | CGRP; Humanized IgG1 | Migraine prevention | NA | 2020 |
[fam]-trastuzumab deruxtecan | Enhertu | HER2; Humanized IgG1 ADC | HER2+ breast cancer | NA | 2019 |
Enfortumab vedotin | Padcev | Nectin-4; Human IgG1 ADC | Urothelial cancer | NA | 2019 |
Crizanlizumab | Adakveo | P-selectin; Humanized IgG2 | Sickle cell disease | Review | 2019 |
Brolucizumab | BEOVU | VEGF-A; Humanized scFv | Macular degeneration | 2020 | 2019 |
Polatuzumab vedotin | Polivy | CD79b; Humanized IgG1 ADC | Diffuse large B-cell lymphoma | 2020 | 2019 |
Risankizumab | Skyrizi | IL-23p19; Humanized IgG1 | Plaque psoriasis | 2019 | 2019 |
Romosozumab | Evenity | Sclerostin; Humanized IgG2 | Osteoporosis in postmenopausal women at risk of fracture | 2019 | 2019 |
Caplacizumab | Cablivi | von Willebrand factor; Humanized Nanobody | Acquired thrombotic thrombo- cytopenic purpura | 2018 | 2019 |
Ravulizumab | Ultomiris | C5; Humanized IgG2/4 | Paroxysmal nocturnal hemoglobinuria | 2019 | 2018 |
Emapalumab | Gamifant | IFNgamma; Human IgG1 | Primary hemophagocytic lymphohistiocytosis | Review | 2018 |
Cemiplimab | Libtayo | PD-1; Human mAb | Cutaneous squamous cell carcinoma | 2019 | 2018 |
Fremanezumab | Ajovy | CGRP; Human IgG2 | Migraine prevention | 2019 | 2018 |
Moxetumomab pasudotox | Lumoxiti | CD22; Murine IgG1 dsFv immunotoxin | Hairy cell leukemia | Review | 2018 |
Galcanezumab | Emgality | CGRP; Human IgG4 | Migraine prevention | 2018 | 2018 |
Lanadelumab | Takhzyro | Plasma kallikrein; Human IgG1 | Hereditary angioedema attacks | 2018 | 2018 |
Mogamuizumab | Poteligeo | CCR4; Humanized IgG1 | Cutaneous T cell lymphoma | 2018 | 2018 |
Erenumab | Aimovig | CGRP receptor; Human IgG2 | Migraine prevention | 2018 | 2018 |
Tildrakizumab | Ilumya | IL-23p19; Humanized IgG1 | Plaque psoriasis | 2018 | 2018 |
Ibalizumab | Trogarzo | CD4; Humanized IgG4 | HIV infection | 2019 | 2018 |
Burosumab | Crysvita | FGF23; Human IgG1 | X-linked hypophosphatemia | 2018 | 2018 |
Durvalumab | IMFINZI | PD-L1; Human IgG1 | Bladder cancer | 2018 | 2017 |
Emicizumab | Hemlibra | Factor IXa, X; Humanized IgG4, bispecific | Hemophilia A | 2018 | 2017 |
Benralizumab | Fasenra | IL-5Rα; Humanized IgG1 | Asthma | 2018 | 2017 |
Ocrelizumab | OCREVUS | CD20; Humanized IgG1 | Multiple sclerosis | 2018 | 2017 |
Guselkumab | TREMFYA | IL-23 P19; Human IgG1 | Plaque psoriasis | 2017 | 2017 |
Inotuzumab ozogamicin | BESPONSA | CD22; Humanized IgG4, ADC | Hematological malignancy | 2017 | 2017 |
Sarilumab | Kevzara | IL-6R; Human IgG1 | Rheumatoid arthritis | 2017 | 2017 |
Dupilumab | Dupixent | IL-4Rα; Human IgG4 | Atopic dermatitis | 2017 | 2017 |
Avelumab | Bavencio | PD-L1; Human IgG1 | Merkel cell carcinoma | 2017 | 2017 |
Brodalumab | Siliq, LUMICEF | IL-17R; Human IgG2 | Plaque psoriasis | 2017 | 2017 |
Atezolizumab | Tecentriq | PD-L1; Humanized IgG1 | Bladder cancer | 2017 | 2016 |
Bezlotoxumab | Zinplava | Clostridium difficileenterotoxin B; Human IgG1 | Prevention of Clostridium difficileinfection recurrence | 2017 | 2016 |
Olaratumab | Lartruvo | PDGRFα; Human IgG1 | Soft tissue sarcoma | 2016 | 2016 |
Reslizumab | Cinqaero, Cinqair | IL-5; Humanized IgG4 | Asthma | 2016 | 2016 |
Obiltoxaximab | Anthim | Protective antigen of B. anthracis exotoxin; Chimeric IgG1 | Prevention of inhalational anthrax | Review | 2016 |
Ixekizumab | Taltz | IL-17a; Humanized IgG4 | Psoriasis | 2016 | 2016 |
Daratumumab | Darzalex | CD38; Human IgG1 | Multiple myeloma | 2016 | 2015 |
Elotuzumab | Empliciti | SLAMF7; Humanized IgG1 | Multiple myeloma | 2016 | 2015 |
Necitumumab | Portrazza | EGFR; Human IgG1 | Non-small cell lung cancer | 2015 | 2015 |
Idarucizumab | Praxbind | Dabigatran; Humanized Fab | Reversal of dabigatran-induced anticoagulation | 2015 | 2015 |
Alirocumab | Praluent | PCSK9; Human IgG1 | High cholesterol | 2015 | 2015 |
Mepolizumab | Nucala | IL-5; Humanized IgG1 | Severe eosinophilic asthma | 2015 | 2015 |
Evolocumab | Repatha | PCSK9; Human IgG2 | High cholesterol | 2015 | 2015 |
Dinutuximab | Unituxin | GD2; Chimeric IgG1 | Neuroblastoma | 2015 | 2015 |
Secukinumab | Cosentyx | IL-17a; Human IgG1 | Psoriasis | 2015 | 2015 |
Nivolumab | Opdivo | PD1; Human IgG4 | Melanoma, non-small cell lung cancer | 2015 | 2014 |
Blinatumomab | Blincyto | CD19, CD3; Murine bispecific tandem scFv | Acute lymphoblastic leukemia | 2015 | 2014 |
Pembrolizumab | Keytruda | PD1; Humanized IgG4 | Melanoma | 2015 | 2014 |
Ramucirumab | Cyramza | VEGFR2; Human IgG1 | Gastric cancer | 2014 | 2014 |
Vedolizumab | Entyvio | α4β7 integrin; Humanized IgG1 | Ulcerative colitis, Crohn disease | 2014 | 2014 |
Siltuximab | Sylvant | IL-6; Chimeric IgG1 | Castleman disease | 2014 | 2014 |
Obinutuzumab | Gazyva | CD20; Humanized IgG1; Glycoengineered | Chronic lymphocytic leukemia | 2014 | 2013 |
Ado-trastuzumab emtansine | Kadcyla | HER2; Humanized IgG1, ADC | Breast cancer | 2013 | 2013 |
Raxibacumab | (Pending) | B. anthrasis PA; Human IgG1 | Anthrax infection | NA | 2012 |
Pertuzumab | Perjeta | HER2; Humanized IgG1 | Breast Cancer | 2013 | 2012 |
Brentuximab vedotin | Adcetris | CD30; Chimeric IgG1, ADC | Hodgkin lymphoma, systemic anaplastic large cell lymphoma | 2012 | 2011 |
Belimumab | Benlysta | BLyS; Human IgG1 | Systemic lupus erythematosus | 2011 | 2011 |
Ipilimumab | Yervoy | CTLA-4; Human IgG1 | Metastatic melanoma | 2011 | 2011 |
Denosumab | Prolia | RANK-L; Human IgG2 | Bone Loss | 2010 | 2010 |
Tocilizumab | RoActemra, Actemra | IL-6R; Humanized IgG1 | Rheumatoid arthritis | 2009 | 2010 |
Ofatumumab | Arzerra | CD20; Human IgG1 | Chronic lymphocytic leukemia | 2010 | 2009 |
Canakinumab | Ilaris | IL-1β; Human IgG1 | Muckle-Wells syndrome | 2009 | 2009 |
Golimumab | Simponi | TNF; Human IgG1 | Rheumatoid and psoriatic arthritis, ankylosing spondylitis | 2009 | 2009 |
Ustekinumab | Stelara | IL-12/23; Human IgG1 | Psoriasis | 2009 | 2009 |
Certolizumab pegol | Cimzia | TNF; Humanized Fab, pegylated | Crohn disease | 2009 | 2008 |
Catumaxomab | Removab | EPCAM/CD3;Rat/mouse bispecific mAb | Malignant ascites | 2009# | NA |
Eculizumab | Soliris | C5; Humanized IgG2/4 | Paroxysmal nocturnal hemoglobinuria | 2007 | 2007 |
Ranibizumab | Lucentis | VEGF; Humanized IgG1 Fab | Macular degeneration | 2007 | 2006 |
Panitumumab | Vectibix | EGFR; Human IgG2 | Colorectal cancer | 2007 | 2006 |
Natalizumab | Tysabri | a4 integrin; Humanized IgG4 | Multiple sclerosis | 2006 | 2004 |
Bevacizumab | Avastin | VEGF; Humanized IgG1 | Colorectal cancer | 2005 | 2004 |
Cetuximab | Erbitux | EGFR; Chimeric IgG1 | Colorectal cancer | 2004 | 2004 |
Efalizumab | Raptiva | CD11a; Humanized IgG1 | Psoriasis | 2004# | 2003# |
Omalizumab | Xolair | IgE; Humanized IgG1 | Asthma | 2005 | 2003 |
Tositumomab-I131 | Bexxar | CD20; Murine IgG2a | Non-Hodgkin lymphoma | NA | 2003# |
Ibritumomab tiuxetan | Zevalin | CD20; Murine IgG1 | Non-Hodgkin lymphoma | 2004 | 2002 |
Adalimumab | Humira | TNF; Human IgG1 | Rheumatoid arthritis | 2003 | 2002 |
Alemtuzumab | MabCampath, Campath-1H; Lemtrada | CD52; Humanized IgG1 | Chronic myeloid leukemia#; multiple sclerosis | 2013; 2001# | 2014; 2001# |
Gemtuzumab ozogamicin | Mylotarg | CD33; Humanized IgG4, ADC | Acute myeloid leukemia | 2018 | 2017; 2000# |
Trastuzumab | Herceptin | HER2; Humanized IgG1 | Breast cancer | 2000 | 1998 |
Infliximab | Remicade | TNF; Chimeric IgG1 | Crohn disease | 1999 | 1998 |
Palivizumab | Synagis | RSV; Humanized IgG1 | Prevention of respiratory syncytial virus infection | 1999 | 1998 |
Basiliximab | Simulect | IL-2R; Chimeric IgG1 | Prevention of kidney transplant rejection | 1998 | 1998 |
Daclizumab | Zenapax; Zinbryta | IL-2R; Humanized IgG1 | Prevention of kidney transplant rejection; multiple sclerosis | 2016; 1999# | 2016; 1997# |
Rituximab | MabThera, Rituxan | CD20; Chimeric IgG1 | Non-Hodgkin lymphoma | 1998 | 1997 |
Abciximab | Reopro | GPIIb/IIIa; Chimeric IgG1 Fab | Prevention of blood clots in angioplasty | 1995* | 1994 |
Edrecolomab | Panorex | EpCAM; Murine IgG2a | Colorectal cancer | 1995*# | NA |
Nebacumab | Centoxin | Endotoxin; Human IgM | Gram-negative sepsis | 1991*# | NA |
Muromonab-CD3 | Orthoclone Okt3 | CD3; Murine IgG2a | Reversal of kidney transplant rejection | 1986* | 1986# |
編集履歴 2020/05/08 はりきり(Mr) 2021/10/17,追記(2021/01~09までのリスト状況)