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Novel FDA Drug Approvals - 2nd Quarter of 2024 - 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. 

2024 | April | May | June

April 2024 – Novel FDA Drug Approvals

Ceftobiprole medocaril

News Release: https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses 

Pegulicianine

  • Drug: Pegulicianine
  • Trade name: Lumisight
  • Therapeutic Area: Breast cancer imaging MeSH D001943
  • Manufacturer: Lumicell
  • FDA Approval Date: April 17, 2024
  • Classification: Fluorescent imaging
  • Drug Class: Malignancy photosensitizers
  • Clinical Trials:      https://www.app.pharmakb.com/drug-report/pegulicianine#clinical 
  • Adverse Events:  https://www.app.pharmakb.com/drug-report/pegulicianine#safety 
  • Description: Pegulicianine, sold under the brand name Lumisight, is an optical imaging agent indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. It is administered by intravenous injection.

News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214511s000lbl.pdf 

Nogapendekin alfa

News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf 

Tovorafenib

News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218033s000lbl.pdf  

Mavorixafor

  • Drug: Mavorixafor
  • Trade name: Xolremdi
  • Therapeutic Area: WHIM syndrome MeSH C536697 
  • Manufacturer: X4 Pharmaceuticals
  • FDA Approval Date: April 26, 2024
  • Classification: Small molecule
  • Drug Class: CXCR receptor antagonists 
  • Clinical Trials:      https://www.app.pharmakb.com/drug-report/mavorixafor#clinical 
  • Adverse Events:  https://www.app.pharmakb.com/drug-report/mavorixafor#safety 
  • Description: Mavorixafor, sold under the brand name Xolremdi, is a CXC chemokine receptor 4 antagonist indicated in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes. It is administered orally.

News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218709s000lbl.pdf 




May 2024 – Novel FDA Drug Approvals

Tarlatamab-dlle

News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf 




June 2024 – Novel FDA Drug Approvals

Imetelstat

News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217779s000lbl.pdf 

Elafibranor

  • Drug: Elafibranor
  • Trade name: Iqirvo
  • Therapeutic Area: Biliary cholangitis MeSH D008105 
  • Manufacturer: GENFIT
  • FDA Approval Date: June 10, 2024
  • Classification: Small molecule
  • Drug Class: PPAR agonist
  • Clinical Trials:   https://www.app.pharmakb.com/drug-report/elafibranor#clinical 
  • Adverse Events:  https://www.app.pharmakb.com/drug-report/elafibranor#safety 
  • Description: Elafibranor, sold under the brand name Iqirvo, is a peroxisome proliferator-activated receptor (PPAR) agonist indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. It is administered orally.

News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218860s000lbl.pdf 

Sofpironium

News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217347s000lbl.pdf 

Crovalimab-akkz

  • Drug: Crovalimab-akkz
  • Trade name: Piasky
  • Therapeutic Area: Paroxysmal nocturnal hemoglobinuria MeSH D006457 
  • Manufacturer: Genentech
  • FDA Approval Date: June 20, 2024
  • Classification: Antibody
  • Drug Class: Monoclonal antibodies
  • Clinical Trials:   https://www.app.pharmakb.com/drug-report/crovalimab#clinical 
  • Adverse Events:  https://www.app.pharmakb.com/drug-report/crovalimab#safety 
  • Description: Crovalimab-akkz, sold under the brand name Piasky, is a complement C5 inhibitor indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria. It is administered by a loading dose administered by intravenous infusion, followed by subcutaneous injection.

News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761388s000lbl.pdf 

Ensifentrine

  • Drug: Ensifentrine
  • Trade name: Ohtuvayre
  • Therapeutic Area: Chronic obstructive pulmonary disease MeSH D029424 
  • Manufacturer: Verona Pharma
  • FDA Approval Date: June 26, 2024
  • Classification: Small molecule
  • Drug Class: Phosphodiesterase inhibitor
  • Clinical Trials:    https://www.app.pharmakb.com/drug-report/ensifentrine#clinical 
  • Adverse Events:  https://www.app.pharmakb.com/drug-report/ ensifentrine#safety 
  • Description: Ensifentrine, sold under the brand name Ohtuvayre, is a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. It is administered through oral inhalation.

News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217389s000lbl.pdf 

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