CDER Annual Drug Approvals 2012-2021 First-in-class Drugs

so

35 54%

lO

I
15

10

2014 2015 2016 2017 2018 2019 2020 2021

2012 2013
Ca•-- Efrartlcimod 1lfa (Vvv11rt)
rn1tokinum1b (Adbry)
ro trut atoplc dermatitis
, oA l ,C.
_y, Pe cce tacopla n (Empavell)
To treat PNH
RoA s.c.
To trut 1ener1llzed my11thenla
arm•
RoAIV/ 1.c.
~henlsm mAb that tarpta Mechanlam Complement Protein C3 binder Mechanism Neonatal Fe receptor
:ytoklne Interleukin 13
~w143875.2 Adbry™ Mw3872.4
Oife llkeflllln (Korsuv1)
binder (FcRN), prevents FcRn from
recyclln, laG back Into blood
,duc1num1b (Aduhe lm)
ro treat Al1h1tmer's (tralokin umab-ldrm) To treat prurltul with 0(0
RoAIV
)lsease Injection 150 mg/ml Mechanltm KOR 1,onllt
loAIV Mw 679.9; docP -0.8; tPSA 222.9
~ TEZSPIRE'"
Tezape lum1b (Te upire)
CJX)(N
g
i.1echanlam l,C.l mAb that
Marlbavlr (Uvte ncltv) H,>-cH, To treet althme
1lncls to Amylold beta
~ BESREf'1_1 To trHt CMV I }-NH OH RoA1.c. c;.,..s
(1e1epelumab-€kko);;:,-:;;;,·
arecate• Mechanism mAb blockln1
.1w145912.3 ~.::!!!- - RoAPO
topecinte rfe ron e lfll•2b (Besre mlJ ~ - -- Mechanlam Cytome11lovtrus
pUL97 kln■M Inhibitor
Cl
thymlc ttromel
lymphopoletln (TSlP)
·o treat polycythemle vera Mw 376.2; closP 2.2; tPSA 99.7 H Mw144590.4 Avacopan (Tavne os)
toAs.c. To treat ANCA vasculltls
.1ec:henlsm mono-pe,vlated type I Interferon RoAPO
0
brex:afune erp (8reu femme) SotorH lb (Lumakras) ~ ................ Mechanism complement CS. recep
·o trHt vaclnal yellt Infection To treat NSCLC •~ I antaconlst
toAPO RoA PO l..__.,.,N N OH
Mw 581.6; docP 6.8; tPSA 61.4
.1echanl1m entifuncal Mechanism IICRASGUC Inhibitor J ~ ~
.1w 730; dotP 3.3; tPSA 125.4 Mw 560.6; closP 3.6; tPSA 102.2 )r vN
1
HND
>devixiba l (Bylv1y) Voclosporln (Lupkynls)
·o treat pruritu1
:oAPO
-hanltm lleal bile acid
To treat lupus nephrltl1 (LN}
RoAPO
Mechanism Celctneurln Inhibitor
Mw 1214,6; cloeP 3.78; tPSA 278.8
a; fa
,. .N "'- I ~ H
1
y O 11 8,;s;,½:
°'
ransporter Inhibitor
,w 740.9; clo,P 6 .3; tPSA 174.4 Be lumosudil (Rezurodl) "'- "'- N O
Tlsotuma b ve dotln (Tlvdak)
rlleclclib (Cosela) To treat 1raft Yefflll host dlHaM H~
To treat cervical cancer
o mttt11te chemotherapy-Induced RoAPO I b
RoAIV
1yelo1uppreulon In patients with li'NY NYiNY N~ NH Mechanism ROCIC2 Inhibitor ~H
Mechanism ADC bind, to tissue
1n1cancer H Mw 452.5; cloeP 4 .65; tPSA 104.8 -N
oAIV
r N~ N~ 'b factor, relHHI MMAE which kl
cells
lechenltm COK4/ 6 Inhibitor ..,.N___} Amivanta ma b (Rybrrnnt)
lw 446,6; clOII' 2.74; tPSA 91.l Evln1cum1b (Evkeeia) mAb
To treat NSO.C To treat homozv,ou• famlllll hypercholetterolemle
1fol1cl1nlne (Cytalux)
RoAIV RoAIV
ptical im111lna qent for ovarian cancer
Mec:henlsm EGFR end MET Mechanism Analopoletlrt-llke protein 3 (ANGPTU) binder
,AIV
receptor directed antibody Mw146083.9
lemenlsm - ftuorncent dnc t1rset1 folllte
Mw145902.2
captor; Mw 1326.S Vosortld e (Voxzoc o)
erlciJuat (Verquvo) Anlfrolum1b (Sephnelo) To treat echondropl11il
, treat chronk: heart failure TotrntSlE RoA1.c.
11A PO RoAIV Mechanism natrluretk peptide receptor type
lechanlsm 1GC stimulator Mechanism TYPe I Interferon B binder (NPft-8); Mw 4102.B
lw 426.4; docP 2 .99; tPSA 146.9 receptor bindinc mAb
sdenopte rin (Nulibry) Mw145119.2
treat patients with the rare 1enetk disuse molybdenum
factor defldency Type A
Loncastuxlmab t eslrlne (Zynlonta )
To treat larse 8-cell lymphoma
8 e lzutif1n (We li re1)
To treat von-Hlppel-Uncleu dl-se
F? I O: I OH
~IV RoAIV RoAPO "'- "'- S0 2
echenlsm Exopnous form of cPMP, repfedns endo1enous
xluctlon ~~~~I~~ ~DC tarptln1 protein CD19 ~~~-~~~!·: ~n~lbltor .. • II I