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2023년 미국 FDA 55종의 신약 허가승인

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2024-01-22 16:16
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미국에서 의약품을 판매하기 위해서는 필수적으로 미국 FDA의 심사를 거쳐서 승인을 받아야 한다.

2023년 한해동안 미국 FDA의 의약품 평가연구센터(CDER: Center for Drug Evaluation and Research)는 총 55종의 신약을 승인하였다. 2022년 허가신약 37건 대비 약 50% 증가한 수치이다.

2023년 승인된 55건의 신약중 28건(51%)이 희귀의약품 지정(Orphan Drug Designation, ODD)을 통하여 승인을 받았으며, 20건(36%)이 혁신신약 (first-in-class)으로 분류되었다.
 
<연도별 FDA 신약허가 건수: 1994~2023>
NMEs: New Molecular Entities(신규 저분자 합성신약), BLAs: Biologics License Applications(생물의약품 품목허가)



 

2023년 승인된 55건의 신약에 대하여

1. 적응증별로 보면,

항암제(Oncology ): 13건, 뇌 또는 신경관련 의약품(Neurology): 9건, 감염병 및 혈액관련 의약품(Infectious diseases & Haematology): 각 5건의 순서로 나타났다.

 

2. 약물유형(Modality)별로 보면,

저분자 합성신약: 34건,

단일클론항체신약 (monoclonal antibody): 12건,

단백질 의약품 (효소대체제, 호르몬, 융합단백질 등): 5건

올리고뉴클레오타이드 (siRNA, antisense ologonucleotides, RNA aptamer 등): 4건

 

3. 신속심사 프로그램 활용

또한 대부분 신약허가신청은 신속하게 심사를 받기 위하여 ‘신속심사프로그램’ 제도를 활용하여 진행되었다. (55건중 49건, 89%).

신속심사프로그램을 이용한 허가심사유형별로 보면


    1. 패스트 트랙(Fast track): 25/55 (45%)
    2. 획기적 치료제 지정(Breakthrough Therapy Designation): 9/55 (16%)
    3. 우선 심사(Priority review): 31/55 (56%)
    4. 신속심사(Accelerated approval): 9/55 (16%)
 
<2023FDA 승인 55종 신약 목록>
순번 성분명
(제품명)
개발사 작용기전(Properties) 적응증(Indication)
1 Lecanemab

(Leqembi)
Eisai/Biogen Amyloid-β-targeted mAb Alzheimer disease
2 Bexagliflozin (Brenzavvy) Theracosbio SGLT2 inhibitor Glycaemic control in type 2 diabetes mellitus
3 Pirtobrutinib

(Jaypirca)
Loxo/Eli Lilly BTK inhibitor Mantle cell lymphoma
4 Elacestrant

(Orserdu)
Stemline ER antagonist ER-positive, HER2-negative, ESR1-mutant breast cancer
5 Daprodustat (Jesduvroq) GSK HIF-PH inhibitor Anaemia caused by CKD for adults on dialysis
6 Velmanase alfa (Lamzede) Chiesi Recombinant α-mannosidase Non-CNS manifestations of α-mannosidosis
7 Sparsentan

(Filspari)
Travere Endothelin and angiotensin II receptor antagonist Proteinuria in primary IgA nephropathy
8 Omaveloxolone (Skyclarys) Reata/Biogen Mechanism unknown, NRF2 activator Friedrich’s ataxia
9 Zavegepant

(Zavzpret)
Pfizer CGRP receptor antagonist Migraine
10 Trofinetide

(Daybue)
Acadia Mechanism unknown Rett syndrome
11 Retifanlimab

(Zynyz)
Incyte PD1-targeted mAb Merkel cell carcinoma
12 Rezafungin

(Rezzayo)
Cidara Echinocandin antifungal Candidemia and invasive candidiasis
13 Leniolisib

(Joenja)
Pharming PI3Kδ inhibitor Activated PI3Kδ syndrome
14 Tofersen

(Qalsody)
Biogen SOD1-targeted ASO SOD1 amyotrophic lateral sclerosis
15 Pegunigalsidase alfa (Elfabrio) Chiesi PEGylated recombinant

α-galactosidase Α
Fabry disease
16 Fezolinetant

(Veozah)
Astellas Neurokinin 3 receptor antagonist Hot flashes caused by menopause
17 Perfluorohexyloctane (Miebo) Bausch + Lomb Semifluorinated alkane Dry eye disease
18 Epcoritamab

(Epkinly)
Genmab/AbbVie CD20 × CD3 T-cell engager DLBCL and high-grade B-cell lymphoma
19 Sulbactam/durlobactam (Xacduro) Entasis β-lactam antibacterial plus a β-lactamase inhibitor Hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible ABC
20 Nirmatrelvir/ritonavir (Paxlovid) Pfizer SARS-CoV-2 main protease inhibitor plus a CYP3A inhibitor Mild-to-moderate COVID-19
21 Flotufolastat F18 (Posluma) Blue Earth Radioactive diagnostic agent PET imaging in prostate cancer
22 Sotagliflozin

(Inpefa)
Lexicon SGLT1/2 inhibitor Heart failure
23 Glofitamab

(Columvi)
Genentech CD20 × CD3 T-cell engager DLBLC or large B-cell lymphoma
24 Ritlecitinib

(Litfulo)
Pfizer JAK3 inhibitor Alopecia areata
25 Rozanolixizumab (Rystiggo) UCB FcRn-targeted mAb AChR- or MuSK-antibody-positive gMG
26 Somatrogon

(Ngenla)
Pfizer Human growth hormone analogue Growth hormone deficiency
27 Nirsevimab

(Beyfortus)
AstraZeneca RSV F protein-targeted mAb RSV lower respiratory tract disease
28 Quizartinib

(Vanflyta)
Daiichi Sankyo FLT3 kinase inhibitor AML
29 Lotilaner

(Xdemvy)
Tarsus Ectoparasiticide Demodex blepharitis
30 Zuranolone

(Zurzuvae)
Sage GABAAreceptor PAM Postpartum depression
31 Avacincaptad pegol (Izervay) Iveric/Astellas C5-targeted aptamer Geographic atrophy secondary to AMD
32 Talquetamab

(Talvey)
Janssen GPRC5D × CD3 T-cell engager Multiple myeloma
33 Elranatamab

(Elrexfio)
Pfizer BCMA × CD3 T-cell engager Multiple myeloma
34 Palovarotene (Sohonos) Ipsen Retinoic acid receptor agonist Fibrodysplasia ossificans progressiva
35 Pozelimab

(Veopoz)
Regeneron C5-targeted mAb CHAPLE disease
36 Motixafortide (Aphexda) Biolinerx CXCR4 inhibitor Hematopoietic stem cell mobilization for autologous transplantation in multiple myeloma
37 Momelotinib

(Ojjaara)
GSK JAK1/2, ALK2 inhibitor Myelofibrosis in adults with anaemia
38 Gepirone

(Exxua)
Fabre-Kramer 5HT1Areceptor agonist Major depressive disorder
39 Cipaglucosidase alfa (Pombiliti) Amicus Recombinant α-glucosidase Pompe disease
40 Nedosiran

(Rivfloza)
Novo Nordisk LDHA-targeted siRNA Primary hyperoxaluria type 1
41 Etrasimod

(Velsipity)
Pfizer S1P receptor modulator Ulcerative colitis
42 Zilucoplan

(Zilbrysq)
UCB Complement C5 inhibitor AChR-antibody positive gMG
43 Bimekizumab

(Bimzelx)
UCB IL-17A/F-targeted mAb Plaque psoriasis
44 Vamorolone

(Agamree)
Santhera Corticosteroid Duchenne muscular dystrophy
45 Mirikizumab

(Omvoh)
Eli Lilly IL-23-targeted mAb Ulcerative colitis
46 Toripalimab

(Loqtorzi)
Coherus PD1-targeted mAb Nasopharyngeal carcinoma
47 Fruquintinib

(Fruzaqla)
Takeda VEGFR1/2/3 kinase inhibitor Colorectal cancer
48 Taurolidine/heparin (Defencath) Cormedix Thiadiazinane antimicrobial plus an anticoagulant Incidence of catheter-related bloodstream infections
49 Repotrectinib (Augtyro) Bristol Myers Squibb ROS1 and TRK kinase inhibitor ROS1-positive NSCLC
50 Efbemalenograstim alfa (Ryzneuta) Evive Recombinant leukocyte growth factor Neutropenia
51 Capivasertib

(Truqap)
AstraZeneca AKT kinase inhibitor Breast cancer
52 Nirogacestat

(Ogsiveo)
Springworks γ-secretase inhibitor Desmoid tumours
53 Iptacopan

(Fabhalta)
Novartis Complement factor B inhibitor Paroxysmal nocturnal haemoglobinuria
54 Birch triterpenes (Filsuvez) Chiesi Mechanism unknown Epidermolysis bullosa
55 Eplontersen

(Wainua)
Ionis/AstraZeneca TTR-targeted ASO hATTR with polyneuropathy
 

55종 신약별 상세한 적응증, 작용기전, 약물유형, 약물구조에 대한 정보는 아래 참조

2023년 1월~4월 사이에 승인된 14종의 신약(순번 1~14)에 대한 정보(바로가기)

2023년 5월~6월 사이에 승인된 12종의 신약(순번 15~26)에 대한 정보(바로가기)

2023년 7월~8월 사이에 승인된 9종의 신약(순번 27~35)에 대한 정보(바로가기)

2023년 9월~12월 사이에 승인된 20종의 신약(순번 36~55)에 대한 정보(바로가기)

작성: 이현규 (한국화학연구원)

<참고자료>
  1. FDA’s Center for Drug Evaluation and Research’s (CDER) 13th annual report, Advancing Health Through Innovation: New Drug Therapy Approvals.(바로가기)
  2. 2023 FDA approvals, Nature Reviews Drug Discovery, 02 January 2024.(바로가기)