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 | January | February | March
January 2024 – Novel FDA Drug Approvals
Berdazimer
- Drug: Berdazimer
- Trade name: Zelsuvmi
- Therapeutic Area: Molluscum contagiosum MeSH D008976
- Manufacturer: Ligand
- FDA Approval Date: January 5, 2024
- Classification: Polymeric
- Drug Class: Topical anti-infective
- Clinical Trials: https://www.app.pharmakb.com/drug-report/berdazimer#clinical
- Adverse Events: e.g. https://www.app.pharmakb.com/drug-report/ berdazimer #safety
- Description: Berdazimer, sold under the brand name Zelsuvmi, is a Topical gel used to treat adult and pediatric molluscum contagiosum.
- News Release: https://zelsuvmi.com/wp-content/uploads/2024/01/Zelsuvmi-Launch-Release-FINAL-APPROVED-post-wire_420PM_5Jan2024.pdf
February 2024 – Novel FDA Drug Approvals
Cefepime/enmetazobactam
- Drug: Cafepime/enmetazobactam
- Trade name: Exblifep
- Therapeutic Area: Complicated urinary tract infections MeSH D014552
- Manufacturer: Allecra
- FDA Approval Date: February 22, 2024
- Classification: Small molecule
- Drug Class: Cephalosporins
- Clinical Trials: https://www.app.pharmakb.com/drug-report/enmetazobactam#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/enmetazobactam#safety
- Description: Cafepime/enmetazobactam, sold under the brand name Exblifep, is a combination product that consists of cefepime, a cephalosporin antibacterial, and enmetazobactam, a beta-lactamase inhibitor to treat complicated urinary tract infections in adults. It is administered via intravenous infusion.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216165s000lbl.pdf
LetibotulinumtoxinA-wlbg
- Drug: LetibotulinumtoxinA-wlbg
- Trade name: Letybo
- Therapeutic Area: To temporarily improve the appearance of moderate-to-severe glabellar lines MeSH D015595
- Manufacturer: Hugel America
- FDA Approval Date: February 29, 2024
- Classification: Small molecule
- Drug Class: Neurotoxin
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ LetibotulinumtoxinA-wlbg #clinical
- Adverse Events: e.g. https://www.app.pharmakb.com/drug-report/ LetibotulinumtoxinA-wlbg #safety
- Description: LetibotulinumtoxinA-wlbg, sold under the brand name Letybo, is a neurotoxin used to treat moderate-to-severe glabellar (frown) lines in adults. It is administered by injection into facial muscles.
March 2024 – Novel FDA Drug Approvals
Tislelizumab-jsgr
- Drug: Tislelizumab
- Trade name: Tevimbra
- Therapeutic Area: Unresectable or metastatic esophageal squamous cell carcinoma MeSH D000077277
- Manufacturer: BeiGene
- FDA Approval Date: March 13, 2024
- Classification: Antibody
- Drug Class: Monoclonal antibody
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ Tislelizumab#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ Tislelizumab#safety
- Description: Tislelizumab-jsgr, sold under the brand name Tevimbra, is used to treat unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy. It is administered as an infusion.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761232Orig1s000lbl.pdf
Resmetirom
- Drug: Resmetirom
- Trade name: Rezdiffra
- Therapeutic Area: noncirrhotic non-alcoholic steatohepatitis (NASH) MeSH D065626
- Manufacturer: Madrigal Pharmaceuticals
- FDA Approval Date: March 14, 2024
- Classification: Small molecule
- Drug Class: Hormone receptor agonists
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ resmetirom#clinical
- Adverse Events: e.g. https://www.app.pharmakb.com/drug-report/ resmetirom#safety
- Description: Resmetirom, sold under the brand name Rezdiffra, is used for the treatment of noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring. It is taken by mouth.
- FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease
Aprocitentan
- Drug: Aprocitentan
- Trade name: Tryvio
- Therapeutic Area: Hypertension MeSH D006973
- Manufacturer: Idorsia Ltd.
- FDA Approval Date: March 19, 2024
- Classification: Small molecule
- Drug Class: Endothelin receptor antagonists
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ aprocitentan#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ aprocitentan#safety
- Description: Aprocitentan, sold under the brand name Tryvio, is used to treat hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. It is taken by mouth.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217686s000lbl.pdf
Givinostat
- Drug: Givinostat
- Trade name: Duvyzat
- Therapeutic Area: Duchenne muscular dystrophy MeSH D020388
- Manufacturer: Italfarmaco
- FDA Approval Date: March 21, 2024
- Classification: Small molecule
- Drug Class: Enzyme inhibitors: histone deacetylase inhibitors; vinca alkaloids
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ givinostat#clinical
- Adverse Events: e.g. https://www.app.pharmakb.com/drug-report/ givinostat#safety
- Description: Givinostat, sold under the brand name Duvyzat, is used to treat Duchenne muscular dystrophy in individuals aged 6 years and older. It is taken by mouth.
- FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-approves-nonsteroidal-treatment-duchenne-muscular-dystrophy
Sotatercept-csrk
- Drug: Sotatercept-csrk
- Trade name: Winrevair
- Therapeutic Area: Pulmonary arterial hypertension MeSH D000081029
- Manufacturer: Merck Sharp & Dohme LLC
- FDA Approval Date: March 26, 2024
- Classification: Protein
- Drug Class: Receptor molecules or membrane ligands, natural, modified or modified: transforming growth factor receptors
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ sotatercept#clinical
- Adverse Events: e.g. https://www.app.pharmakb.com/drug-report/ sotatercept#safety
- Description: Sotatercept-csrk, sold under the brand name Winrevair, is used to treat pulmonary arterial hypertension to increase exercise capacity, to improve WHO functional class (FC) and reduce the risk of clinical worsening events. It is administered by subcutaneous injection.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761363s000lbl.pdf
Vadadustat
- Drug: Vadadustat
- Trade name: Vafseo
- Therapeutic Area: Anemia due to chronic kidney disease MeSH D051436, D000740
- Manufacturer: Akebia Therapeutics
- FDA Approval Date: March27, 2024
- Classification: Small molecule
- Drug Class: Enzyme inhibitors: hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ vadadustat#clinical
- Adverse Events: e.g. https://www.app.pharmakb.com/drug-report/ vadadustat#safety
- Description: Vadadustat, sold under the brand name Vafseo, is used for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. It is taken by mouth.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215192s000lbl.pdf
Danicopan
- Drug: Danicopan
- Trade name: Voydeya
- Therapeutic Area: Extravascular hemolysis with paroxysmal nocturnal hemoglobinuria MeSH D006461, D006457
- Manufacturer: Alexion Pharmaceuticals
- FDA Approval Date: March 29, 2024
- Classification: Small molecule
- Drug Class: Complement receptor antagonists/complement inhibitors
- Clinical Trials: https://www.app.pharmakb.com/drug-report/danicopan#clinical
- Adverse Events: e.g. https://www.app.pharmakb.com/drug-report/danicopan#safety
- Description: Danicopan, sold under the brand name Voydeya, is as an add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). It is taken by mouth.
FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218037Orig1s000ltr.pdf
