Monthly Novel FDA Drug Approvals - PharmaKB Report - February 2023

The Pharmaceutical KnowledgeBase (PharmaKB.com) provides research and financial intelligence about companies and their approved drugs as well as drug candidates in clinical trials. In this monthly PharmaKB report, we provide an update about four novel drugs approved by the US FDA in January of this year.  By referencing new drugs as “novel” the FDA is confirming that the medicine being approved contains ingredients and/or a mechanism of action that the FDA hasn’t previously approved. 

February 2023 – Novel FDA Drug Approvals

Daprodustat

• Drug: Daprodustat
• Trade name: Jesduvroq
• Therapeutic Areas: Anemia MeSH D000740; Allergic bronchopulmonary aspergillosis MeSH D001229
• Manufacturer: GSK
• FDA Approval Date: February 1, 2023 (via New Drug Application)
• Classification: Small molecule
• Drug Class: enzyme inhibitors: hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors
• Clinical Trials: https://www.pharmakb.com/drug-report/daprodustat#clinical-trials   
• Adverse Events: https://www.pharmakb.com/drug-report/daprodustat#adverse
• Description: Daprodustat, sold under the brand name Jesduvroq and Duvroq, among others, is a medication that is used for the treatment of anemia due to chronic kidney disease. It is a hypoxia-inducible factor prolyl hydroxylase inhibitor. It is taken by mouth.
• FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-anemia-caused-chronic-kidney-disease-adults-dialysis 

Velmanase alfa-tycv

• Drug: Velmanase alfa
• Trade name: Lamzede
• Therapeutic Areas: Hereditary congenital and neonatal diseases and abnormalities MeSH D009358; nutritional and metabolic diseases MeSH D009750.
• Manufacturer: Chiesi Farmaceutici
• FDA Approval Date: February 16, 2023
• Classification: Enzyme
• Drug Class: Enzymes
• Clinical Trials: https://www.pharmakb.com/drug-report/velmanase20alfa#clinical-trials
• Adverse Events: https://www.pharmakb.com/drug-report/velmanase20alfa#adverse
• Description: Velmanase alfa, sold under the brand name Lamzede, is a medication used for the treatment of alpha-mannosidosis. Velmanase alfa is a recombinant human lysosomal alpha-mannosidase. It is administered by infusion.
• FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-roundup-february-17-2023

Sparsentan

• Drug: Sparsentan
• Trade name:  Filspari
• Therapeutic Areas: Iga glomerulonephritis MeSH D005922; Focal segmental glomerulosclerosis MeSH D005923.
• Manufacturer: Travere Therapeutics
• FDA Approval Date: February 17, 2023 (via FDA Accelerated Approval Program)
• Classification: Small molecule
• Drug Class: Endothelin receptor antagonists
• Clinical Trials:  https://www.pharmakb.com/drug-report/sparsentan#clinical-trials
• Adverse Events: https://www.pharmakb.com/drug-report/sparsentan#adverse
• Description: Sparsentan, sold under the brand name Filspari, is a medication used for the treatment of primary immunoglobulin A nephropathy. Sparsentan is an endothelin and angiotensin II receptor antagonist. It is taken by mouth.
• FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216403Orig1s000ltr.pdf

Omaveloxolone

• • Drug: Omaveloxolone
  • Trade name:  Skyclarys
  • Therapeutic Areas: Friedreich’s ataxia MeSH D005621
  • Manufacturer: Reata Pharmaceuticals
  • FDA Approval Date: February 28, 2023 (via FDA Accelerated Approval Program)
  • Classification: Small molecule
  • Drug Class: Steroids (not prednisolone derivatives)
  • Clinical Trials:  https://www.pharmakb.com/drug-report/omaveloxolone#clinical-trials
  • Adverse Events: https://www.pharmakb.com/drug-report/omaveloxolone#adverse 
  • Description: Omaveloxolone, sold under the brand name Skyclarys, is a medication used for the treatment of Friedreich's ataxia. It is taken by mouth.
  • FDA News Release: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-friedreichs-ataxia