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. 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.
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://www.pharmakb.com/drug-report/zavegepant#clinical-trials
- Adverse Events: https://www.pharmakb.com/drug-report/zavegepant#adverse
- 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://www.pharmakb.com/drug-report/trofinetide#clinical-trials
- Adverse Events: https://www.pharmakb.com/drug-report/trofinetide#adverse
- 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://www.pharmakb.com/drug-report/retifanlimab#clinical-trials
- Adverse Events: https://www.pharmakb.com/drug-report/retifanlimab#adverse
- 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://www.pharmakb.com/drug-report/rezafungin#clinical-trials
- Adverse Events: https://www.pharmakb.com/drug-report/rezafungin#adverse
- 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
