Novel FDA Drug Approvals - 1st Quarter of 2023 - PharmaKB Report

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 quarterly PharmaKB report, we provide an update about novel drugs approved by the US FDA in 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. 

2023 | January | February | March 

January 2023 – Novel FDA Drug Approvals

Lecanemab

• Drug: Lecanemab
• Trade name: Leqembi
• Therapeutic Area: Alzheimer’s Disease (nervous system diseases MeSH D009422 | mental disorders MeSH D001523)
• Manufacturer: Eisai
• FDA Approval Date: January 6, 2023 (via FDA Accelerated Approval Program)
• Classification: Antibody
• Drug Class: Monoclonal antibodies
• Clinical Trials: https://app.pharmakb.com/drugs/Lecanemab#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Lecanemab#safety
• Description: Lecanemab, sold under the brand name Leqembi, is a monoclonal antibody medication used for the treatment of Alzheimer's disease. Lecanemab is an amyloid beta-directed antibody, delivered via intravenous infusion.
• FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment

Bexagliflozin

• Drug: Bexagliflozin
• Trade name: Brenzavvy
• Therapeutic Area: Type 2 diabetes mellitus (MeSH D003924) and essential hypertension (MeSH https://www.ncbi.nlm.nih.gov/mesh/?term=D000075222)
• Manufacturer: TheracosBio
• FDA Approval Date: January 23, 2023
• Classification: Small molecule
• Drug Class: Phlorozin derivatives, phenolic glycosides
• Clinical Trials: https://app.pharmakb.com/drugs/Bexagliflozin#clinical 
• Adverse Events: https://app.pharmakb.com/drugs/Bexagliflozin#safety 
• Description: Brenzavvy (bexagliflozin) is a small molecule pharmaceutical approved to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. This medicine is administered orally in 20 milligram tablet form.
• FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214373s000lbl.pdf

Pirtobrutinib

• Drug: Pirtobrutinib
• Trade name:  Jaypirca
• Therapeutic Area: Relapsed or refractory mantle cell lymphoma (MCL) (MeSH D020522)
• Manufacturer: Eli Lilly and Company
• FDA Approval Date: January 27, 2023 (via FDA Accelerated Approval Program)
• Classification: Small molecule
• Drug Class: Tyrosine kinase inhibitors: tyrosine kinase inhibitors Bruton's (Btk) inhibitors
• Clinical Trials:  https://app.pharmakb.com/drugs/Pirtobrutinib#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Pirtobrutinib#safety 
• Description: Pirtobrutinib, sold under the brand name Jaypirca, is an anticancer medication that is used to treat mantle cell lymphoma. It inhibits B cell lymphocyte proliferation and survival by binding and inhibiting Bruton's tyrosine kinase (BTK). It is taken by mouth.
• FDA News Release: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-relapsed-or-refractory-mantle-cell-lymphoma 

Elacestrant

• Drug: Elacestrant
• Trade name:  Orserdu
• Therapeutic Area: Breast cancer (MeSH D001943)
• Manufacturer: Stemline Therapeutics
• FDA Approval Date: January 27, 2023
• Classification: Small molecule
• Drug Class: Estrogens; estrogen antagonists
• Clinical Trials:  https://app.pharmakb.com/drugs/Elacestrant#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Elacestrant#safety
• Description: Elacestrant, sold under the brand name Orserdu, is an anticancer medication which is used in the treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. It is taken by mouth.
• FDA News Release: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer 

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://app.pharmakb.com/drugs/Daprodustat#clinical   
• Adverse Events: https://app.pharmakb.com/drugs/Daprodustat#safety
• 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://app.pharmakb.com/drugs/Velmanase%20alfa#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Velmanase%20alfa#safety
• 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://app.pharmakb.com/drugs/Sparsentan#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Sparsentan#safety
• 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://app.pharmakb.com/drugs/Omaveloxolone#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Omaveloxolone#safety 
• 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 

March 2023 – Novel FDA Drug Approvals

Zavegepant

• Drug:  Zavegepant
• Trade name:  Zavzpret
• Therapeutic Areas:  Migraine disorders MeSH D008881; Covid-19 MeSH D000086382
• Manufacturer:  Mylan
• FDA Approval Date:  March 9, 2023
• Classification:  Small molecule 
• Drug Class:  Calcitonin gene-related peptide receptor antagonists
• Clinical Trials:  https://app.pharmakb.com/drugs/Zavegepant#clinical
• Adverse Events:  https://app.pharmakb.com/drugs/Zavegepant#safety
• Description:  Zavegepant, sold under the trade name Zavzpret, isZavegepant is a calcitonin gene-related peptide receptor antagonist. It is sprayed into the nose. It is sold by Pfizer.
• FDA News Release:  https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216386Orig1s000ltr.pdf

Trofinetide

• Drug:  Trofinetide
• Trade name:  Daybue
• Therapeutic Areas:  Rett syndrome MeSH D015518; brain injuries MeSH D001930; fragile x syndrome MeSH D005600
• Manufacturer:  Acadia Pharmaceuticals
• FDA Approval Date:  March 10, 2023
• Classification:  Small molecule
• Drug Class:  Peptides: neuropeptide Y (NPY) receptors and analogues
• Clinical Trials:  https://app.pharmakb.com/drugs/Trofinetide#clinical 
• Adverse Events:  https://app.pharmakb.com/drugs/Trofinetide#safety 
• Description:  Trofinetide, sold under the brand name Daybue, is a medication used for the treatment of Rett syndrome. It is taken by mouth.
• FDA News Release:  https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-rett-syndrome

Zynyz

• Drug:  Zynyz
• Trade name:  Retifanlimab
• Therapeutic Areas:  Non-small-cell lung carcinoma MeSH D002289; squamous cell carcinoma of head and neck MeSH D000077195; Head and neck neoplasms MeSH D006258
• Manufacturer:  Incyte Corporation
• FDA Approval Date:  March 22, 2023
• Classification:  Antibody
• Drug Class:  Monoclonal antibodies
• Clinical Trials:  https://app.pharmakb.com/drugs/Retifanlimab#clinical
• Adverse Events:  https://www.pharmakb.com/drug-report/retifanlimab#safety
• Description:  Retifanlimab, sold under the brand name Zynyz, is an anti-cancer medication used for the treatment of Merkel cell carcinoma. Retifanlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.
• FDA News Release:  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-zynyz-retifanlimab-dlwr-metastatic-or-recurrent-locally

Rezafungin

• Drug:  Rezafungin
• Trade name:  Rezzayo
• Therapeutic Areas: Mycoses MeSH D009181; candidemia MeSH D058387; invasive candidiasis MeSH D058365; fungemia D016469
• Manufacturer:  Cidara Therapeutics
• FDA Approval Date:  March 22, 2023
• Classification:  Small molecule 
• Drug Class:  Antifungal antibiotics
• Clinical Trials:  https://app.pharmakb.com/drugs/Retifanlimab#clinical
• Adverse Events:  https://app.pharmakb.com/drugs/Retifanlimab#safety
• Description:  Rezafungin, sold under the name Rezzayo, is an antifungal drug of the echinocandin class.
• FDA News Release:  https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217417Orig1s000Approv.pdf