Table 1. Novel Drugs Approved by the US Food and Drug Administration in 2020a.
| Drug | Brand name | Approval date | Sponsor | Indication |
|---|---|---|---|---|
| Avapritinib | Ayvakit | 01/09/20 | Blueprint Medicines | Treatment of unresectable or metastatic gastrointestinal stromal tumor |
| Teprotumumab-trbw | Tepezza | 01/21/20 | Horizon Therapeutics Ireland | Treatment of thyroid eye disease |
| Tazemetostat | Tazverik | 01/23/20 | Epizyme | Epithelioid sarcoma |
| Lactitol | Pizensy | 02/12/20 | Braintree Labs | Treatment of chronic idiopathic constipation |
| Bempedoic acid | Nexletol | 02/21/20 | Esperion Therapeutics | Treatment of heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Eptinezumab-jjmr | Vyepti | 02/21/20 | Lundbeck Seattle BioPharmaceuticals | Preventive treatment of migraines |
| Amisulpride | Barhemsys | 02/26/20 | Acacia | Preventive treatment of postoperative nausea and vomiting |
| Rimegepant | Nurtec ODT | 02/27/20 | Biohaven Pharmaceuticals | Treatment of migraines |
| Isatuximab-irfc | Sarclisa | 03/02/20 | Sanofi Aventis US | Treatment (adjunctive therapy) of refractory multiple myeloma |
| Osilodrostat | Isturisa | 03/06/20 | Novartis | Treatment of Cushing disease in which pituitary gland surgery has failed or is contraindicated |
| Ozanimod | Zeposia | 03/25/20 | Celgene | Treatment of relapsing forms of multiple sclerosis |
| Selumetinib | Koselugo | 04/10/20 | AstraZeneca | Treatment of neurofibromatosis type 1 |
| Tucatinib | Tukysa | 04/17/20 | Seattle Genetics | Treatment (adjunctive therapy) of advanced unresectable or metastatic ERBB2-positive breast cancer |
| Pemigatinib | Pemazyre | 04/17/20 | Incyte | Treatment of locally advanced or metastatic cholangiocarcinoma |
| Sacituzumab govitecan-hziy | Trodelvy | 04/22/20 | Immunomedics | Treatment of metastatic triple-negative breast cancer |
| Opicapone | Ongentys | 04/24/20 | Neurocrine Biosciences | Treatment (adjunctive therapy) of “off” episodes in Parkinson disease |
| Capmatinib | Tabrecta | 05/06/20 | Novartis | Treatment of non–small cell lung cancer |
| Selpercatinib | Retevmo | 05/08/20 | Loxo Oncology | Treatment of metastatic non–small cell lung cancer and thyroid cancers |
| Ripretinib | Qinlock | 05/15/20 | Deciphera Pharmaceuticals | Treatment of gastrointestinal stromal tumor |
| Artesunate | Artesunate | 05/26/20 | Amivas | Treatment of severe malaria |
| Inebilizumab-cdon | Uplizna | 06/11/20 | Viela Biopharmaceuticals | Treatment of neuromyelitis optica spectrum disorder |
| Lurbinectedin | Zepzelca | 06/15/20 | Pharma Mar USA | Treatment of metastatic small cell lung cancer |
| Triheptanoin | Dojolvi | 06/30/20 | Ultragenyx Pharmaceuticals | Treatment of long-chain fatty acid oxidation disorders |
| Remimazolam | Byfavo | 07/02/20 | Acacia | Induction and maintenance of procedural sedation |
| Fostemsavir | Rukobia | 07/02/20 | Viiv Healthcare Company | Treatment (adjunctive therapy) of HIV-1 |
| Decitabine and cedazuridine | Inqovi | 07/07/20 | Astex Pharmaceuticals | Treatment of myelodysplastic syndromes |
| Abametapir | Xeglyze | 07/24/20 | Dr Reddy’s Laboratories | Treatment of head lice |
| Tafasitamab-cxix | Monjuvi | 07/31/20 | MorphoSys US | Treatment (adjunctive therapy) of relapsed or refractory diffuse large B-cell lymphoma |
| Belantamab mafodotin-blmf | Blenrep | 08/05/20 | GlaxoSmithKline | Treatment of relapsed or refractory multiple myeloma |
| Nifurtimox | Lampit | 08/06/20 | Bayer Healthcare | Treatment of Chagas disease in pediatric patients younger than 18 years |
| Risdiplam | Evrysdi | 08/07/20 | Genentech | Treatment of spinal muscular atrophy |
| Oliceridine | Olinvyk | 08/07/20 | Trevena | Management of severe acute pain |
| Viltolarsen | Viltepso | 08/12/20 | Nippon Shinyaku | Treatment of Duchenne muscular dystrophy |
| Satralizumab-mwge | Enspryng | 08/14/20 | Genentech | Treatment of neuromyelitis optica spectrum disorder |
| Clascoterone | Winlevi | 08/26/20 | Cassiopea SpA | Treatment of acne vulgaris |
| Somapacitan-beco | Sogroya | 08/28/20 | Novo Nordisk | Treatment of growth hormone deficiency |
| Pralsetinib | Gavreto | 09/04/20 | Genentech | Treatment of non–small cell lung cancer |
| Atoltivimab, maftivimab, and odesivimab-ebgn | Inmazeb | 10/14/20 | Regeneron | Treatment of Ebola virus |
| Remdesivir | Veklury | 10/22/20 | Gilead Sciences | Treatment of COVID-19 |
| Lonafarnib | Zokinvy | 11/20/20 | Eiger BioPharmaceuticals | Reduction of mortality risk in rare genetic diseases that cause premature aging |
| Lumasiran | Oxlumo | 11/23/20 | Alnylam Pharmaceuticals | Treatment of primary hyperoxaluria type 1 |
| Setmelanotide | Imcivree | 11/25/20 | Rhythm Pharmaceuticals | Treatment of obesity and hunger control due to proopiomelanocortin deficiency |
| Naxitamab-gqgk | Danyelza | 11/25/20 | Y-mAbs Therapeutics | Treatment (adjunctive therapy) of refractory or relapsed high-risk neuroblastoma |
| Berotralstat | Orladeyo | 12/03/20 | BioCryst Pharmaceuticals | Preventive treatment for attacks of hereditary angioedema |
| Tirbanibulin | Klisyri | 12/14/20 | Athenex | Treatment of actinic keratosis of the face or scalp |
| Margetuximab (anti-ERBB2 mAb | Margenza | 12/16/20 | MacroGenics | Treatment of metastatic ERBB2-positive breast cancer |
| Relugolix | Orgovyx | 12/18/20 | Myovant Sciences | Treatment of advanced prostate cancer |
| Ansuvimab-zykl | Ebanga | 12/21/20 | Ridgeback Biotherapeutics | Treatment of Ebola virus |
| Vibegron | Gemtesa | 12/23/20 | Urovant Sciences | Treatment of overactive bladder |
a
Excludes 4 diagnostic agents that were approved by the FDA in 2020.