Meds Entry Watch - New Medicines Approved in 2020

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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


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
1 (HIV-1) infection1

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


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


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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