Meds Entry Watch - New Medicines Approved in 2020
The following table provides supplementary information on the manufacturer and approved indication(s) for each medicine that received first-time market authorization by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2020.
Indications for new medicines approved by the FDA, the EMA, and/or Health Canada in 2020
Medicine (trade name)* | Approved indications | Manufacturer |
---|---|---|
Ansuvimab-zykl (Ebanga)B,O |
Indicated to treat Ebola2 |
Ridgeback Biotherapeutics |
Atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb)B,O |
Indicated to treat Ebola2 |
Jazz Pharmaceuticals |
Avapritinib (Ayvakyt)C,O |
Indicated to treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST)2 |
Blueprint Medicines Corporation |
Belantamab mafodotin (Blenrep)B,C,O |
Indicated to treat multiple myeloma2 |
GlaxoSmithKline |
Bempedoic acid (Nexletol) |
Indicated to treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C2 |
Esperion Therapeutics, Inc. |
Berotralstat (Orladeyo)B |
Indicated to treat patients with hereditary angioedema2 |
BioCryst Pharmaceuticals, Inc. |
Brexucabtagene autoleucel (Tecartus)B,C,G,O |
Indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)2 |
Kite Pharma, Inc. |
Bulevirtide (Hepcludex)B,O |
Indicated to treat chronic (long-term) hepatitis delta virus (HDV) infection in adults with compensated liver disease (when the liver is damaged but is still able to work), when the presence of viral RNA (genetic material) has been confirmed by blood tests.3 |
Gilead Sciences Ireland UC |
Cabotegravir (Vocabria) |
Indicated for short-term treatment of human immunodeficiency virus type |
ViiV Healthcare ULC |
Capmatinib (Tabrecta)C,O |
Indicated to treat patients with non-small-cell lung cancer2 |
Novartis Pharmaceuticals Corp. |
Cedazuridine (Inqovi)C,O |
Indicated to treat adult patients with myelodysplastic syndromes1 |
Otsuka Pharmaceutical Co., Ltd |
Clascoterone (Winlevi) |
Indicated to treat acne2 |
Sun Pharmaceutical Industries Ltd |
Coagulation factor VIIa (Recombinant) (Sevenfact) B |
Indicated for treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors2 |
Laboratoire francais du fractionnement et des biotechnologies S.A. |
COVID-19 MRNA vaccine (Comirnaty)B |
Indicated for preventing coronavirus disease 2019 (COVID-19) in people aged 5 years and older3 |
BioNTech Manufacturing GmbH |
Eptinezumab (Vyepti)B |
Indicated for the preventive treatment of migraine in adults2 |
Lundbeck Seattle BioPharmaceuticals, Inc. |
Filgotinib (Jyseleca)B |
Indicated for treating adults with moderate to severe rheumatoid arthritis3 |
Gilead Sciences Ireland UC |
Fostemsavir trometamol (Rukobia) |
Indicated to treat HIV2 |
ViiV Healthcare ULC |
Imlifidase (Idefirix)B |
Indicated to prevent the body from rejecting a newly transplanted kidney3 |
Hansa Biopharma AB |
Inebilizumab (Uplizna)B,O |
Indicated to treat neuromyelitis optica spectrum disorder2 |
Viela Bio, Inc. |
Isatuximab (Sarclisa)B,C,O |
Indicated to treat multiple myloma1 |
Sanofi-Aventis Canada Inc. |
Lonafarnib (Zokinvy)O |
Indicated to treat rare conditions related to premature aging 2 |
Eiger BioPharmaceuticals |
Lumasiran (Oxlumo)O |
Indicated to treat hyperoxaluria type 12 |
Alnylam Pharmaceuticals Inc. |
Lurbinectedin (Zepzelca)C,O |
Indicated to treat metastatic small cell lung cancer2 |
Jazz Pharmaceuticals |
Naxitamab (Danyelza)B,C,O |
Indicated to treat high-risk refractory or relapsed neuroblastoma2 |
Y-mAbs Therapeutics, Inc. |
Oliceridine (Olinvyk) |
Indicated to manage acute pain in certain adults2 |
Trevena Inc. |
Osilodrostat (Isturisa)O |
Indicated to treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease2 |
Recordati Rare Diseases Inc. |
Ozanimod (Zeposia) |
Indicated to treat relapsing forms of multiple sclerosis1 |
Celgene Inc. |
Pemigatinib (Pemazyre)C,O |
Indicated to treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts2 |
Incyte Corp. |
Pralsetinib (Gavreto)C,O |
Indicated to treat non-small-cell lung cancer2 |
Genentech USA, Inc. |
Relugloix (Orgovyx)C |
Indicated to treat advanced prostate cancer2 |
Myovant Sciences Ltd |
Remdesivir (Veklury) |
Indicated to treat COVID-191 |
Gilead Sciences Canada Inc. |
Remimazolam (Anerem) |
Indicated for sedation2 |
Acacia Pharma Ltd |
Rimegepant (Nurtec) |
Indicated to treat migraine2 |
Biohaven Pharmaceuticals |
Ripretinib (Qinlock)C,O |
Indicated to treat advanced gastrointestinal-stromal tumors1 |
Deciphera Pharmaceuticals, LLC |
Risdiplam (Evrysdi)O |
Indicated to treat spinal muscular atrophy2 |
Genentech USA, Inc. |
Sacituzumab govitecan (Trodelvy)B,C |
Indicated to treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease2 |
Immunomedics Inc. |
Satralizumab (Enspryng)B,O |
Indicated to treat neuromyelitis optica spectrum disorder1 |
Hoffmann-La Roche Ltd |
Selpercatinib (Retevmo)C,O |
Indicated to treat lung and thyroid cancers2 |
Eli Lilly and Co. |
Selumetinib (Koselugo)O |
Indicated to treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves2 |
AstraZeneca |
Setmelanotide (Imcivree)O |
Indicated to treat obesity and the control of hunger associated with pro-opiomelanocortin deficiency, a rare disorder that causes severe obesity that begins at an early age2 |
Rhythm Pharmaceuticals, Inc. |
Somapacitan (Sogroya)B |
Indicated as a growth hormone2 |
Novo Nordisk, Inc. |
Tafasitamab (Monjuvi)B,C,O |
Indicated to treat relapsed or refractory diffuse large B-cell lymphoma2 |
MorphoSys US, Inc. |
Tazemetostat (Tazverik)C,O |
Indicated to treat epithelioid sarcoma2 |
Epizyme, Inc. |
Teprotumumab (Tepezza)B,O |
Indicated to treat thyroid eye disease2 |
Horizon Therapeutics |
Tirbanibulin (Klisyri) |
Indicated to treat actinic Keratosis of the face or scalp2 |
Almirall |
Triheptanoin (Dojolvi)O |
Indicated to treat molecularly long-chain fatty acid oxidation disorders2 |
Ultragenyx Pharmaceutical Inc. |
Tucatinib (Tukysa)C,O |
Indicated to treat advanced unresectable or metastatic HER2-positive breast cancer2 |
Seagen Inc. |
Vibegron (Gemtesa, Beova) |
Indicated to treat overactive bladder2 |
Urovant Sciences |
Viltolarsen (Viltepso)O |
Indicated to treat Duchenne muscular dystrophy2 |
NS Pharma, Inc. |
Indications from 1 Health Canada; 2 US Food and Drug Administration (FDA); 3 European Medicines Agency (EMA).
* B: biologic; C: cancer; G: gene therapy; O: orphan medicine.
Data source: US Food and Drug Administration Novel Drugs 2020; European Medicines Agency Human Medicines Highlights 2020; Health Canada databases.
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