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BIOLOGICS mAb

[抗体/情報] 年々増える抗体医薬 – Antibody Societyでは抗体医薬がリストされている – ID15492 [2020/05/08]

[抗体/情報] 年々増える抗体医薬 – Antibody Societyでは抗体医薬がリストされている – ID15492 [2020/05/08]

スポンサーリンク: ID6183593457

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 nameTarget; Format1st indication approved / reviewed1st EU approval year1st US approval year
Sutimlimab(Pending)C1s; Humanized IgG4Cold agglutinin diseaseNAReview
Aducanumab(Pending)Amyloid beta; Human IgG1Alzheimer’s diseaseNAReview
Teplizumab(Pending)CD3; Humanized IgG1Type 1 diabetesNAReview
Dostarlimab(Pending)PD-1; Humanized IgG4Endometrial cancerReviewReview
Tanezumab(Pending)Nerve growth factor; Humanized IgG2Osteoarthritis painReviewReview
Margetuximab(Pending)HER2; Chimeric IgG1HER2+ breast cancerNAReview
Naxitamab(Pending)GD2; Humanized IgG1High-risk neuroblastoma and refractory osteomedullary diseaseNAReview
Belantamab mafodotin(Pending)BCMA; Humanized IgG1 ADCMultiple myelomaReviewReview
Oportuzumab monatox(Pending)EpCAM; Humanized scFv immunotoxinBladder cancerNAReview
REGNEB3(Pending)Ebola virus; mixture of 3 human IgG1Ebola virus infectionNAReview
Narsoplimab(Pending)MASP-2; Human IgG4Hematopoietic stem cell transplant-associated thrombotic microangiopathiesNAReview
Tafasitamab(Pending)CD19; Humanized IgG1Diffuse large B-cell lymphomaNAReview
Satralizumab(Pending)IL-6R; Humanized IgG2Neuromyelitis optica and neuromyelitis optica spectrum disordersReviewReview
Inebilizumab(Pending)CD19; Humanized IgG1Neuromyelitis optica and neuromyelitis optica spectrum disordersNAReview
Leronlimab(Pending)CCR5; Humanized IgG4HIV infectionNAReview
Sacituzumab govitecanTrodelvyTROP-2; Humanized IgG1 ADCTriple-neg. breast cancerNA 2020
TeprotumumabTepezzaIGF-1R; Human IgG1Thyroid eye diseaseNA2020
IsatuximabSarclisaCD38; Chimeric IgG1Multiple myelomaReview2020
EptinezumabVyeptiCGRP; Humanized IgG1Migraine preventionNA2020
[fam]-trastuzumab deruxtecanEnhertuHER2; Humanized IgG1 ADCHER2+ breast cancerNA2019
Enfortumab vedotinPadcevNectin-4; Human IgG1 ADCUrothelial cancerNA2019
CrizanlizumabAdakveoP-selectin; Humanized IgG2Sickle cell diseaseReview2019
BrolucizumabBEOVUVEGF-A; Humanized scFvMacular degeneration20202019
Polatuzumab vedotinPolivyCD79b; Humanized IgG1 ADCDiffuse large B-cell lymphoma20202019
RisankizumabSkyriziIL-23p19; Humanized IgG1Plaque psoriasis20192019
RomosozumabEvenitySclerostin; Humanized IgG2Osteoporosis in postmenopausal women at risk of fracture20192019
CaplacizumabCablivivon Willebrand factor; Humanized NanobodyAcquired thrombotic thrombo- cytopenic
purpura
20182019
RavulizumabUltomirisC5; Humanized IgG2/4Paroxysmal nocturnal hemoglobinuria20192018
EmapalumabGamifantIFNgamma; Human IgG1Primary hemophagocytic lymphohistiocytosisReview2018
CemiplimabLibtayoPD-1; Human mAbCutaneous squamous cell carcinoma20192018
FremanezumabAjovyCGRP; Human IgG2Migraine prevention20192018
Moxetumomab pasudotoxLumoxitiCD22; Murine IgG1 dsFv immunotoxinHairy cell leukemiaReview2018
GalcanezumabEmgalityCGRP; Human IgG4Migraine prevention20182018
LanadelumabTakhzyroPlasma kallikrein; Human IgG1Hereditary angioedema attacks20182018
MogamuizumabPoteligeoCCR4; Humanized IgG1Cutaneous T cell lymphoma20182018
ErenumabAimovigCGRP receptor; Human IgG2Migraine prevention20182018
TildrakizumabIlumyaIL-23p19; Humanized IgG1Plaque psoriasis20182018
IbalizumabTrogarzoCD4; Humanized IgG4HIV infection20192018
BurosumabCrysvitaFGF23; Human IgG1X-linked hypophosphatemia20182018
DurvalumabIMFINZIPD-L1; Human IgG1Bladder cancer20182017
EmicizumabHemlibraFactor IXa, X; Humanized IgG4, bispecificHemophilia A20182017
BenralizumabFasenraIL-5Rα; Humanized IgG1Asthma20182017
OcrelizumabOCREVUSCD20; Humanized IgG1Multiple sclerosis20182017
GuselkumabTREMFYAIL-23 P19; Human IgG1Plaque psoriasis20172017
Inotuzumab
ozogamicin
BESPONSACD22; Humanized IgG4, ADCHematological malignancy20172017
SarilumabKevzaraIL-6R; Human IgG1Rheumatoid arthritis20172017
DupilumabDupixentIL-4Rα; Human IgG4Atopic dermatitis20172017
AvelumabBavencioPD-L1; Human IgG1Merkel cell carcinoma20172017
BrodalumabSiliq, LUMICEFIL-17R; Human IgG2Plaque psoriasis20172017
AtezolizumabTecentriqPD-L1; Humanized IgG1Bladder cancer20172016
BezlotoxumabZinplavaClostridium difficileenterotoxin B; Human IgG1Prevention of Clostridium difficileinfection recurrence20172016
OlaratumabLartruvoPDGRFα; Human IgG1Soft tissue sarcoma20162016
ReslizumabCinqaero, CinqairIL-5; Humanized IgG4Asthma20162016
ObiltoxaximabAnthimProtective antigen of B. anthracis exotoxin; Chimeric IgG1Prevention of inhalational anthraxReview2016
IxekizumabTaltzIL-17a; Humanized IgG4Psoriasis20162016
DaratumumabDarzalexCD38; Human IgG1Multiple myeloma20162015
ElotuzumabEmplicitiSLAMF7; Humanized IgG1Multiple myeloma20162015
NecitumumabPortrazzaEGFR; Human IgG1Non-small cell lung cancer20152015
IdarucizumabPraxbindDabigatran;
Humanized Fab
Reversal of dabigatran-induced anticoagulation20152015
AlirocumabPraluentPCSK9; Human IgG1High cholesterol20152015
MepolizumabNucalaIL-5; Humanized IgG1Severe eosinophilic asthma20152015
EvolocumabRepathaPCSK9; Human IgG2High cholesterol20152015
DinutuximabUnituxinGD2; Chimeric IgG1Neuroblastoma20152015
SecukinumabCosentyxIL-17a; Human IgG1Psoriasis20152015
NivolumabOpdivoPD1; Human IgG4Melanoma, non-small cell lung cancer20152014
BlinatumomabBlincytoCD19, CD3; Murine bispecific tandem scFvAcute lymphoblastic leukemia20152014
PembrolizumabKeytrudaPD1; Humanized IgG4Melanoma20152014
RamucirumabCyramzaVEGFR2; Human IgG1Gastric cancer20142014
VedolizumabEntyvioα4β7 integrin; Humanized IgG1Ulcerative colitis, Crohn disease20142014
SiltuximabSylvantIL-6; Chimeric IgG1Castleman disease20142014
ObinutuzumabGazyvaCD20; Humanized IgG1; GlycoengineeredChronic lymphocytic leukemia20142013
Ado-trastuzumab emtansineKadcylaHER2; Humanized IgG1, ADCBreast cancer20132013
Raxibacumab(Pending)B. anthrasis PA; Human IgG1Anthrax infectionNA2012
PertuzumabPerjetaHER2; Humanized IgG1Breast Cancer20132012
Brentuximab vedotinAdcetrisCD30; Chimeric IgG1, ADCHodgkin lymphoma, systemic anaplastic large cell lymphoma20122011
BelimumabBenlystaBLyS; Human IgG1Systemic lupus erythematosus20112011
IpilimumabYervoyCTLA-4; Human IgG1Metastatic melanoma20112011
DenosumabProliaRANK-L; Human IgG2Bone Loss20102010
TocilizumabRoActemra, ActemraIL-6R; Humanized IgG1Rheumatoid arthritis20092010
OfatumumabArzerraCD20; Human IgG1Chronic lymphocytic leukemia20102009
CanakinumabIlarisIL-1β; Human IgG1Muckle-Wells syndrome20092009
GolimumabSimponiTNF; Human IgG1Rheumatoid and psoriatic arthritis, ankylosing spondylitis20092009
UstekinumabStelaraIL-12/23; Human IgG1Psoriasis20092009
Certolizumab pegolCimziaTNF; Humanized Fab, pegylatedCrohn disease20092008
CatumaxomabRemovabEPCAM/CD3;Rat/mouse bispecific mAbMalignant ascites2009#NA
EculizumabSolirisC5; Humanized IgG2/4Paroxysmal nocturnal hemoglobinuria20072007
RanibizumabLucentisVEGF; Humanized IgG1 FabMacular degeneration20072006
PanitumumabVectibixEGFR; Human IgG2Colorectal cancer20072006
NatalizumabTysabria4 integrin; Humanized IgG4Multiple sclerosis20062004
BevacizumabAvastinVEGF; Humanized IgG1Colorectal cancer20052004
CetuximabErbituxEGFR; Chimeric IgG1Colorectal cancer20042004
EfalizumabRaptivaCD11a; Humanized IgG1Psoriasis2004#2003#
OmalizumabXolairIgE; Humanized IgG1Asthma20052003
Tositumomab-I131BexxarCD20; Murine IgG2aNon-Hodgkin lymphomaNA2003#
Ibritumomab tiuxetanZevalinCD20; Murine IgG1Non-Hodgkin lymphoma20042002
AdalimumabHumiraTNF; Human IgG1Rheumatoid arthritis20032002
AlemtuzumabMabCampath, Campath-1H; LemtradaCD52; Humanized IgG1Chronic myeloid leukemia#; multiple sclerosis2013;
2001#
2014;
2001#
Gemtuzumab
ozogamicin
MylotargCD33; Humanized IgG4, ADCAcute myeloid leukemia20182017;
2000#
TrastuzumabHerceptinHER2; Humanized IgG1Breast cancer20001998
InfliximabRemicadeTNF; Chimeric IgG1Crohn disease19991998
PalivizumabSynagisRSV; Humanized IgG1Prevention of respiratory syncytial virus infection19991998
BasiliximabSimulectIL-2R; Chimeric IgG1Prevention of kidney transplant rejection19981998
DaclizumabZenapax; ZinbrytaIL-2R; Humanized IgG1Prevention of kidney transplant rejection; multiple sclerosis2016;
1999#
2016;
1997#
RituximabMabThera, RituxanCD20; Chimeric IgG1Non-Hodgkin lymphoma19981997
AbciximabReoproGPIIb/IIIa; Chimeric IgG1 FabPrevention of blood clots in angioplasty1995*1994
EdrecolomabPanorexEpCAM; Murine IgG2aColorectal cancer1995*#NA
NebacumabCentoxinEndotoxin; Human IgMGram-negative sepsis1991*#NA
Muromonab-CD3Orthoclone Okt3CD3; Murine IgG2aReversal of kidney transplant rejection1986*1986#
2020/05/01現在のリトス
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)

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スポンサーリンク ID 7130582967

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