The novel drugs marketed in 2018

56

Motegrity

prucalopride

2018-12-14

5-HT4 receptor agonist

Chronic idiopathic constipation

J & J/Shire

55

Xospata

gilteritinib

2018-11-28

Axl/Flt3 inhibitor

r/r-AML

Astellas Pharma

54

Firdapse

amifampridine

2018-11-28

Potassium channel blocker

Lambert-Eaton myasthenic syndrome

Catalyst Pharmaceuticals

53

Vitrakvi

larotrectinib

2018-11-26

TRK inhibitor

Advanced solid tumors harboring an NTRK gene fusion

Loxo Oncology

52

Daurismo

glasdegib

2018-11-21

SMO receptor agonist

Acute leukemia

Pfizer

51

Gamifant

emapalumab

2018-11-20

INFγ mAb

Primary hemophagocytic lymphohistiocytosis

Novimmune sobi

50

Aemcolo

rifamycin

2018-11-16

Rifamycin

Travelers’ diarrhea

Cosmo Pharmaceuticals

49

Yupelri

revefenacin

2018-11-8

mAChR inhibitor

Chronic obstructive pulmonary disease

Theravance Biopharma; Mylan

48

Lorbrena

lorlatinib

2018-11-2

ALK inhibitor

ALK-positive NSCLC

Pfizer

47

Xofluza

baloxavir marboxil

2018-10-24

Small molecule inhibitor of cap-dependent endonuclease

Influenza

Roche

46

Talzenna

talazoparib

2018-10-16

PARP inhibitor

Locally advanced or metastatic breast cancer

Pfizer

45

Tegsedi

inotersen

2018-10-5

TTR antisense therapy

Polyneuropathy of hereditary transthyretin-mediated amyloidosis

Ionis pharmaceuticals; GSK

44

Revcovi

elapegademase-lvlr

2018-10-5

Recombinant adenosine deaminase

Adenosine Deaminase-Severe Combined Immunodeficiency

Leadiant Biosciences

43

Nuzyra

omadacycline

2018-10-3

Tetracycline antibiotic

ABSSSI; CABP

Paratek Pharmaceuticals

42

Seysara

sarecycline

2018-10-1

Tetracycline antibiotic

Acne vulgaris

Allergan

41

Libtayo

cemiplimab-rwlc

2018-9-28

Anti-PD-1 mAb

Metastatic/locally advanced CSCC

Regeneron

40

Vizimpro

dacomitinib

2018-9-27

EGFR tyrosine kinase inhibitor

NSCLC

Pfizer

39

Emgality

galcanezumab-gnlm

2018-9-27

CGRP mAb

Migraine

Eli Lilly;Arteaus Therapeutics

38

Copiktra

duvelisib

2018-9-24

PI3K inhibitor

r/r-CLL, r/r-SLL, r/r-follicular lymphoma

Verastem Oncology

37

Ajovy

fremanezumab-vfrm

2018-9-14

CGRP mAb

Cluster headache

Teva

36

Lumoxiti

moxetumomab pasudotox-tdfk

2018-9-13

Anti-siglec-2 immunotoxin drug

Hairy cell leukemia

AstraZeneca

35

Pifeltro

doravirine

2018-8-30

Reverse transcriptase (RT)

HIV

MSD

34

Xerava

eravacycline

2018-8-27

Tetracycline

Complicated urinary tract infection

Everest Medicines;

33

Takhzyro

lanadelumab

2018-8-23

KLK mAb

Hereditary angioedema

Shire

32

Oxervate

cenegermin-bkbj

2018-8-22

Recombinant nerve growth factor

Neurotrophic keratitis

Dompé Farmaceutici

31

Diacomit

stiripentol

2018-8-20

NA

Dravet syndrome

BIOCODEX SAS

30

Galafold

migalastat

2018-8-10

α-galactosidase promoter

Fabry disease

Amicus Therapeutics

29

Annovera

segesterone acetate and ethinyl estradiol vaginal system

2018-8-10

Segesterone+ethinyloestradiol

Pregnancy prevention

The Population Council

28

Onpattro

patisiran

2018-8-10

TTR RNAi

Polyneuropathy of hereditary transthyretin-mediated amyloidosis

Alnylam; Sanofi

27

Poteligeo

mogamulizumab-kpkc

2018-8-8

CCR4 mAb

Rare, hard-to-treat types of non-Hodgkin lymphoma

Kyowa Hakko Kirin Co., Ltd.

26

Mulpleta

lusutrombopag

2018-7-31

TPO receptor agonist

Thrombocytopenia caused by chronic liver disease

Shionogi

25

Omegaven

fish oil triglycerides

2018-7-27

Intravenous emulsion with triglycerides

Cholestasis

Fresenius Kabi

24

Orilissa

elagolix sodium

2018-7-23

Gonadotropin-releasing hormone (GnRH) receptor antagonist

Endometriosis

AbbVie

23

Krintafel

tafenoquine

2018-7-20

Aminoquinoline drug

Plasmodium vivax malaria

GSK

22

Tibsovo

ivosidenib

2018-7-20

IDH1 inhibitor

Relapsed or refractory acute myeloid leukemia

Agios Pharmaceuticals

21

TPOXX

tecovirimat

2018-7-13

P37 protein inhibitor

Smallpox

SIGA Technologies

20

Braftovi

encorafenib

2018-6-27

 BRAF inhibitor

BRAFV600E/V600K+ metastatic melanoma

Array BioPharma

19

Mektovi

binimetinib

2018-6-27

 BRAF inhibitor

BRAFV600E/V600K+ metastatic melanoma

Array BioPharma

18

Zemdri

plazomicin

2018-6-25

Aminoglycoside antibiotic

Urinary tract infections

Achaogen

17

Epidiolex

cannabidiol

2018-6-25

NA

Lennox-Gastaut syndrome and Dravet syndrome

GW Pharmaceuticals

16

Moxidectin

moxidectin

2018-6-13

Macrolide antibiotic

Onchocerciasis

Medicines Development for Global Health

15

Olumiant

baricitinib

2018-5-31

JAK1/2 inhibitor

Moderately to severely active rheumatoid arthritis

Eli Lilly

14

Palynziq

pegvaliase-pqpz

2018-5-24

Recombinant phenylalanine ammonia lyase

Phenylketonuria

BioMarin

13

Doptelet

avatrombopag

2018-5-21

TPO receptor agonist

Low blood platelet count caused by chronic liver disease

Dova Pharmaceuticals

12

Lokelma

sodium zirconium cyclosilicate

2018-5-18

NA

Hyperkalemia

AstraZeneca

11

Aimovig

erenumab-aooe

2018-5-17

CGRP mAb

Migraine

Amgen/Novartis

10

Lucemyra

lofexidine hydrochloride

2018-5-16

α-2 adrenergic receptor agonist

Treatment for management of opioid withdrawal symptoms

US Worldmeds

9

Akynzeo

fosnetupitant and palonosetron

2018-4-19

5-HT3 receptor agonist+NK1 receptor agonist

Acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy

Helsinn Healthcare

8

Crysvita

burosumab-twza

2018-4-17

Anti-FGF23 mAb

Adults and children with x-linked hypophosphatemia (XLH)

Ultragenyx

7

Tavalisse

fostamatinib

2018-4-17

Syk inhibitor

Chronic immune thrombocytopenia

Rigel pharms

6

Ilumya

tildrakizumab

2018-3-20

Anti-IL-23 mAb

Moderate-to-severe plaque psoriasis

Sun Pharmaceutical

5

Trogarzo

ibalizumab-uiyk

2018-03-6

Anti-CD4 mAb

Drug resistant HIV

TaiMed Biologics

4

Erleada

apalutamide

2018-2-14

Androgen receptor inhibitor

Non-metastatic, castration-resistant prostate cancer

J & J

3

Symdeko

tezacaftor; ivacaftor

2018-2-13

CFTR (compound)

Cystic fibrosis

Vertex pharmaceticals

2

Biktarvy

bictegravir, embitcitabine, tenofovir alafenamide

2018-2-7

TAF-component integrase inhibitor drugs

HIV

Gilead

1

Lutathera

lutetium Lu 177 dotatate

2018-1-26

Lu-177-labeled somatostatin analogues

Gastroenteropancreatic neuroendocrine tumors

Advanced Accelerator Applications