New Medicines Approved in 2021 - Meds Entry Watch
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 2021.
Indications from
- Health Canada
- US Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
| Medicine (trade name) Footnote* | Approved indications | Manufacturer |
|---|---|---|
| Abrocitinib (Cibinqo) | Health CanadaHealth CanadaDermatitis | Pfizer Canada ULC |
| Aducanumab (Aduhelm)B | US Food and Drug Administration US Food and Drug AdministrationAlzheimer’s disease | Biogen Inc. |
| Allogeneic processed thymus tissue (Rethymic)B | US Food and Drug AdministrationPediatric congenital athymia | Enzyvant Therapeutics GmbH |
| Amivantamab (Rybrevant)B | Health CanadaNon-small cell lung cancer | Janssen Inc. |
| Anifrolumab (Saphnelo)B | Health CanadaSystemic lupus erythematousus | AstraZeneca Canada Inc. |
| Asciminib (Scemblix)C | Health CanadaPhiladelphia chromosome-positive chronic myeloid leukemia | Novartis Pharmaceuticals |
| Atogepant (Qulipta) | Health CanadaMigraines | AbbVie Corporation |
| Avacopan (Tavneos)O | Health CanadaSevere active anti-neutrophil cytoplasmic autoantibody-associated vasculitis | Vifor Fresenius Medical Care Renal Pharma Ltd |
| Avalglucosidase alfa (Nexviazyme)B | Health CanadaLate-onset Pompe disease | Sanofi-Aventis Canada Inc. |
| Belumosudil (Rezurock)O | Health CanadaChronic graft-versus-host disease | Sanofi-Aventis Canada Inc. |
| Belzutifan (Welireg)O | Health CanadaVon Hippel-Lindau disease | Merck Canada Inc. |
| Bimekizumab (Bimzelx)B | Health CanadaPsoriasis | UCB Canada Inc. |
| Casimersen (Amondys-45)O | US Food and Drug AdministrationDuchenne muscular dystrophy | Sarepta Therapeutics inc. |
| Casirivimab (Ronapreve)B | European Medicines AgencyCOVID-19 treatment | Roche Registration GmbH |
| Dasiglucagon (Zegalogue) | US Food and Drug AdministrationSevere hypoglycemia | Zealand Pharma |
| Difelikefalin (Korsuva) | Health CanadaPruritus | Vifor Fresenius Medical Care Renal Pharma Ltd |
| Dostarlimab (Jemperli)B | Health CanadaEndometrial cancer | GlaxoSmithKline Inc. |
| Efgartigimod (Vyvgart)B | US Food and Drug AdministrationGeneralized myasthenia gravis | Argenx B.V. |
| Estetrol (Nextstellis) | European Medicines Agency (EMA)Pregnancy prevention | Gedeon Richter Plc. |
| Evinacumab (Evkeeza)B | US Food and Drug AdministrationHomozygous familial hypercholesterolemia | Regeneron Pharmaceuticals |
| Fexinidazole (Fexinidazole)O | US Food and Drug AdministrationHuman African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense | Sanofi |
| Finerenone (Kerendia) | US Food and Drug AdministrationTo reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes | Bayer Healthcare |
| Fosdenopterin (Nulibry) | US Food and Drug AdministrationTo reduce the risk of mortality in molybdenum cofactor deficiency Type A | Sentynl Therapeutics, Inc. |
| Ibrexafungerp (Brexafemme) | US Food and Drug AdministrationVulvovaginal candidiasis | Scynexis |
| Idecabtagene vicleucel (Abecma)B | Health CanadaRelapsed or refractory multiple myeloma | Celgene Inc. |
| Infigratinib (Truseltiq)C | Health CanadaCholangiocarcinoma | QED Therapeutics, Inc. |
| Lisocabtagene maraleucel (Breyanzi)B | Health CanadaRelapsed or refractory large B-cell lymphoma | Celgene Inc. |
| Lonapegsomatropin (Skytrofa)B | US Food and Drug AdministrationTo treat short stature due to inadequate secretion of endogenous growth hormone | Ascendis Pharma, Encocrinology Div A/S |
| Loncastuximab tesirine (Zynlonta)B | Health CanadaRelapsed or refractory large B-cell lymphoma | ADC Therapeutics SA |
| Maralixibat (Livmarli)O | US Food and Drug AdministrationTo treat cholestatic pruritus associated with Alagille syndrome | Mirum Pharmaceuticals |
| Maribavir (Livtencity) | US Food and Drug AdministrationTo treat post-transplant cytomegalovirus (CMV) infection/disease | Takeda Pharmaceuticals USA, Inc. |
| Melphalan flufenamide (Pepaxto)C | US Food and Drug AdministrationTo treat relapsed or refractory multiple myeloma | Oncopeptides AB |
| Mobocertinib (Exkivity)C | US Food and Drug AdministrationTo treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations | Takeda Pharmaceuticals USA, Inc. |
| Odevixibat (Bylvay)O | US Food and Drug AdministrationTo treat pruritus | Albireo |
| Pafolacianine (Cytalux)C | US Food and Drug AdministrationTo help identify ovarian cancer lesions | Press ReleaseOn Target Laboratories |
| Pegcetacoplan (Empaveli)O | US Food and Drug AdministrationTo treat paroxysmal nocturnal hemoglobinuria | Apellis Pharmaceuticals |
| Ponesimod (Ponvory) | US Food and Drug AdministrationTo treat relapsing forms of multiple sclerosis | Janssen Pharmaceuticals |
| Regdanvimab (Regkirona)B | European Medicines Agency (EMA)COVID-19 treatment | Celltrion Healthcare Hungary Kft. |
| Roxadustat (Evrenzo) | European Medicines Agency (EMA)Anaemia | Astellas Pharma Europe B.V. |
| Samidorphan (Lybalvi) | US Food and Drug AdministrationSchizophrenia and certain aspects of bipolar I isorder | Alkermes Inc. |
| Serdexmethylphenidate (Azstarys) | US Food and Drug AdministrationAttention deficit hyperactivity disorder | Commave Therapeutics SA |
| Somatrogon (Ngenla)B | Health CanadaGrowth hormone deficiency | Pfizer Canada ULC |
| Sotorasib (Lumakras)C | Health CanadaTypes of non-small cell lung cancer | Amgen Canada Inc. |
| Sotrovimab (Xevudy)B | European Medicines Agency (EMA)COVID-19 treatment | GlaxoSmithKline Trading Services Limited |
| Tepotinib (Tepmetko)C | Health CanadaNon-small cell lung cancer | EMD Serono, A Division of EMD Inc. CANADA |
| Tezepelumab (Tezspire)B | US Food and Drug AdministrationSevere asthma as an add-on maintenance therapy | AstraZeneca AB |
| Tisotumab vedotin (Tivdak)B | US Food and Drug AdministrationRecurrent or metastatic cervical cancer with disease progression on or after chemotherapy | Seagen |
| Tralokinumab (Adtralza)B | US Food and Drug AdministrationModerate-to-severe atopic dermatitis | LEO Pharma A/S |
| Trilaciclib (Cosela)C | US Food and Drug AdministrationTo mitigate chemotherapy-induced myelosuppression in small cell lung cancer | G1 Therapeutics, Inc. |
| Umbralisib (Ukoniq)C | US Food and Drug AdministrationMarginal zone lymphoma and follicular lymphoma | TG Therapeutics |
| Vaccine, SARS-CoV-2 non-replicating vector (VAC COV2 NRV J.J.)B | US Food and Drug AdministrationCOVID-19 prevention | Janssen Pharmaceuticals |
| Vericiguat (Verquvo) | US Food and Drug AdministrationTo mitigate the risk of cardiovascular death and hospitalization for chronic heart failure | Merck Sharp & Dohme |
| Viloxazine (Qelbree) | US Food and Drug AdministrationAttention deficit hyperactivity disorder | Supernus Pharmaceuticals |
| Voclosporin (Lupkynis) | US Food and Drug AdministrationLupus nephritis | Aurinia Pharmaceuticals |
| Vosoritide (Voxzogo)O | US Food and Drug AdministrationTo improve growth in children five years of age and older with achondroplasia and open epiphyses | BioMarin Pharmaceutical Inc. |
Data source: US Food and Drug Administration Novel Drugs 2021; European Medicines Agency Human Medicines Highlights 2021; Health Canada databases.
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