Monthly Novel FDA Drug Approvals - PharmaKB Report - January 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. 

January 2023 – Novel FDA Drug Approvals

The US FDA approved four novel drugs in January 2023:

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://www.pharmakb.com/drug-report/lecanemab#clinical
• Adverse Events: https://www.pharmakb.com/drug-report/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://www.pharmakb.com/drug-report/bexagliflozin#clinical 
• Adverse Events: https://www.pharmakb.com/drug-report/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://www.pharmakb.com/drug-report/elacestrant#clinical
• Adverse Events: https://www.pharmakb.com/drug-report/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