Table 1: Selected FDA new drug approvals in Q3 2018

From: FDA new drug approvals in Q3 2018

DateDrug (brand name; company)PropertiesIndication2024 global sales forecast
13 JulTecovirimat (TPOXX; SIGA Technologies)Viral P37 protein inhibitorSmallpoxNA
20 JulIvosidenib (Tibsovo; Agios Pharmaceuticals)IDH1 inhibitorAML$926 million
20 JulTafenoquine (Krintafel; MMV/GSK)NAMalariaNA
23 JulElagolix (Orilissa; Neurocrine Biosciences/AbbVie)GnRH antagonistPain associated with endometriosis$1,508 million
27 JulFish oil triglycerides (Omegaven; Fresenius)NAMalnutritionNA
31 JulLusutrombopag (Mulpleta; Shionogi)TPO receptor agonistThrombocytopaenia$38 million
8 AugMogamulizumab (Poteligeo; Kyowa Hakko Kirin)CCR4 mAbCutaneous T cell lymphoma$72 million
10 AugSegesterone acetate and ethinyl estradiol (Annovera; TherapeuticsMD)PR agonist and ER agonistFemale contraceptionNA
10 AugMigalastat (Galafold; Amicus Therapeutics)α-Galactosidase regulatorFabry disease$546 million
10 AugPatisiran (Onpattro; Alnylam Pharmaceuticals)TTR RNAiTTR-mediated amyloidosis$953 million
20 AugStiripentol (Diacomit: Biocodex)GABA reuptake inhibitorDravet syndromeNA
22 AugCenegermin (Oxervate; Dompé)Recombinant NGFOcular infectionsNA
23 AugLanadelumab (Takhzyro; Shire)KLK mAbHereditary angioedema$1,542 million
27 AugEravacycline (Xerava; Tetraphase Pharmaceuticals)Tetracycline antibioticIntra-abdominal infections$219 million
30 AugDoravirine (Pifeltro; Merck & Co.)HIV NNRTIHIV$186 million
13 SepMoxetumomab pasudotox (Lumoxiti; AstraZeneca)CD22-directed cytotoxinHairy cell leukaemia$132 million
14 SepFremanezumab (Ajovy; Teva)CGRP mAbMigraine$896 million
24 SepDuvelisib (Copiktra ; Verastem Oncology)PI3K inhibitorCLL, FL and SLL$326 million
27 SepDacomitinib (Vizimpro; Pfizer)EGFR inhibitorEGFR-mutant NSCLC$336 million
27 SepGalcanezumab (Emgality; Eli Lilly)CGRP mAbMigraine$944 million
28 SepCemiplimab (Libtayo; Regeneron/Sanofi)PD1 mAbCSCC$611 million
  1. AML, acute myeloid leukaemia; CCR4, CC-chemokine receptor 4; CGRP; calcitonin gene-related peptide; CLL, chronic lymphocytic leukaemia; CSCC; cutaneous squamous cell carcinoma; EGFR, epidermal growth factor receptor; ER, oestrogen receptor; FL, follicular lymphoma; GnRH; gonadotropin-releasing hormone; GSK, GlaxoSmithKline; IDH, isocitrate dehydrogenase 1; KLK, kallikrein; mAb, monoclonal antibody; MMV, Medicines for Malaria Venture; NA, not available; NGF, nerve growth factor; NNRTI, non-nucleoside reverse transcriptase inhibitor; NSCLC, non-small-cell lung cancer; PI3K, phosphatidylinositol 3-kinase; PR, progesterone receptor; RNAi, RNA interference; SLL, small lymphocytic lymphoma; TPO, thrombopoietin; TTR, transthyretin.