New Medicines Approved in 2022 - 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 2022.
Indications from
- 1 Health Canada
- 2 US Food and Drug Administration (FDA)
- 3 European Medicines Agency (EMA)
| Medicine (trade name) Footnote* | Approved indications | Manufacturer |
|---|---|---|
| Adagrasib (Krazati)C,O | To treat KRAS G12C‑mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy2 | Mirati Therapeutics |
| Ciltacabtagene autoleucel (Carvykti)B,C,O | For the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody2 | Janssen Biotech |
| Daridorexant (Quviviq) | To treat insomnia2 | Idorsia |
| Daxibotulinumtoxina (Daxxify)B | To treat moderate‑to‑severe glabellar lines associated with corrugator and/or procerus muscle activity2 | Revance Therapeutics |
| Deucravacitinib (Sotyktu) | To treat moderate‑to‑severe plaque psoriasis2 | Bristol Myers Squibb |
| Eflapegrastim (Rolvedon)B | To decrease the incidence of infection in patients with non‑myeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with clinically significant incidence of febrile neutropenia2 | Spectrum Pharma |
| Eladocagene exuparvovec (Upstaza)B,G,O | For the treatment of aromatic L‑amino acid decarboxylase (AADC) deficiency3 | PTC Therapeutics |
| Etranacogene dezaparvovec (Hemgenix)B,O | For treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes2 | CSL Behring |
| Faricimab (Vabysmo)B | To treat neovascular (wet) aged‑related macular degeneration and diabetic macular edema2 | Genentech |
| Fecal microbiota (live) (Rebyota)B,O | For the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI2 | Ferring Pharmaceuticals |
| Futibatinib (Lytgobi)C,O | To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements2 | Taiho Oncology |
| Ganaxolone (Ztalmy)O | To treat seizures in cyclin‑dependent kinase‑like 5 deficiency disorder2 | Marinus |
| Lenacapavir (Sunlenca) | To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations3 | Gilead Sciences |
| Lutetium (177Lu) vipivotide tetraxetan (Pluvicto)C | To treat prostate‑specific membrane antigen‑positive metastatic castration‑resistant prostate cancer following other therapies2 | Novartis |
| Mavacamten (Camzyos)O | To treat certain classes of obstructive hypertrophic cardiomyopathy2 | Bristol Myers Squibb |
| Mirvetuximab soravtansine (Elahere)B,C,O | To treat patients with recurrent ovarian cancer that is resistant to platinum therapy2 | ImmunoGen |
| Mitapivat (Pyrukynd)O | To treat hemolytic anemia in pyruvate kinase deficiency2 | Agios Pharmaceuticals |
| Mosunetuzumab (Lunsumio)B,C,O | To treat adults with relapsed or refractory follicular lymphoma, a type of non‑Hodgkin lymphoma3 | Genentech |
| Nadofaragene firadenovec (Adstiladrin)B,C,O | For the treatment of adult patients with high‑risk Bacillus Calmette‑Guérin (BCG)‑unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors2 | Ferring Pharmaceuticals |
| Nirmatrelvir (Paxlovid) | For the treatment of COVID‑191 | Pfizer Canada |
| Nirsevimab (Beyfortus)B | For the prevention of RSV lower respiratory tract disease in neonates and infants3 | AstraZeneca |
| Olipudase alfa (Xenpozyme)B,O | To treat Acid Sphingomyelinase Deficiency3 | Sanofi |
| Olutasidenib (Rezlidhia)C,O | To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase‑1 (IDH1) mutation2 | Rigel Pharmaceuticals |
| Omidenepag (Eybelis) | To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension2 | Visiox Pharmaceuticals |
| Oteseconazole (Vivjoa) | To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential2 | Mycovia Pharmaceuticals |
| Pacritinib (Vonjo)O | To treat intermediate or high‑risk primary or secondary myelofibrosis in adults with low platelets2 | CTI BioPharma |
| Palovarotene (Sohonos)O | For the treatment of heterotopic ossification and fibrodysplasia ossificans progressiva1 | Ipsen |
| Relatlimab (Opdualag)B,C,O | To treat unresectable or metastatic melanoma2 | Bristol Myers Squibb |
| Spesolimab (Spevigo)B,O | To treat generalized pustular psoriasis flares2 | Boehringer Ingelheim |
| Sutimlimab (Enjaymo)B,O | To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease2 | Bioverativ Therapeutics |
| Tabelecleucel (Ebvallo)C,O | For the treatment of Epstein‑Barr virus positive post‑transplant lymphoproliferative disease3 | Pierre Fabre Pharma |
| Tapinarof (Vtama) | To treat plaque psoriasis2 | Dermavant Sciences |
| Tebentafusp (Kimmtrak)B,C,O | To treat unresectable or metastatic uveal melanoma2 | Immunocore |
| Teclistamab (Tecvayli)B,C,O | To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy3 | Janssen Biotech |
| Teplizumab (Tzield)B | To delay the onset of stage 3 type 1 diabetes2 | Provention Bio |
| Terlipressin (Terlivaz)O | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function2 | Mallinckrodt Pharmaceuticals Ireland |
| Tirzepatide (Mounjaro) | To improve blood sugar control in diabetes, in addition to diet and exercise2 | Eli Lilly and Company |
| Tixagevimab (Evusheld)B | For the treatment of COVID‑193 | AstraZeneca |
| Tremelimumab (Imjudo)B,C,O | To treat unresectable hepatocellular carcinoma2 | AstraZeneca |
| Ublituximab (Briumvi)B,O | To treat relapsing forms of multiple sclerosis2 | TG Therapeutics |
| Ursodoxicoltaurine (Relyvrio)O | To treat amyotrophic lateral sclerosis (ALS)1 | Amylyx Pharmaceuticals |
| Vaccine, dengue fever (Dengvaxia)B | Dengue fever vaccine2 | Sanofi Pasteur |
| Vaccine, SARS-CoV-2 (Nuvax)B | COVID‑19 vaccine3 | Novavax |
| Vaccine, SARS-CoV-2 subunit (Nuvaxovid)B | COVID‑19 vaccine3 | Novavax |
| Valoctocogene roxaparvovec (Roctavian)B,G,O | For the treatment of hemophilia3 | BioMarin Pharmaceutical |
| Virus-like particles (VLP) of SARS-CoV-2 spike protein (Covifenz)B | COVID‑19 vaccine1 | Medicago |
| Vonoprazan (Takecab) | To treat Helicobacter pylori infection2 | Takeda |
| Vutrisiran (Amvuttra)O | To treat polyneuropathy of hereditary transthyretin‑mediated amyloidosis2 | Alnylam Pharmaceuticals |
Data source: US Food and Drug Administration Novel Drugs 2022; European Medicines Agency Human Medicines Highlights 2022; Health Canada databases.
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