Venatorx Confident in Quick Resolution of Manufacturing Concerns for Cefepime-Taniborbactum Antibiotic Despite FDA Setback

- Venatorx and Melinta Therapeutics faced a setback when the FDA rejected their New Drug Application (NDA) for cefepime-taniborbactam, a combination antibiotic intended for treating complicated urinary tract infections (cUTIs).
- The FDA identified manufacturing issues and requested additional chemistry, manufacturing, and controls (CMC) data about the drug, testing methods, and manufacturing process.
- Notably, the FDA did not raise concerns about clinical safety or efficacy, nor did they request new clinical trials.
- Based on a phase 3 trial, cefepime-taniborbactam showed superiority to meropenem in patients with complicated UTIs.
- Venatorx CEO Dr. Christopher J. Burns expressed confidence in the drug and stated that the company would generate the required CMC data while working closely with the FDA to expedite patient availability.
- The drug has been supported by various organizations, including the Biomedical Advanced Research and Development Authority (BARDA), which provided a $318 million contract for the development and procurement of cefepime-taniborbactam for treating melioidosis, a respiratory disease caused by the bacterium Burkholderia pseudomallei.
- Venatorx has collaborated with Melinta Therapeutics for commercialization in the United States, and there are international agreements with Menarini Group and Everest Medicines for distribution and commercialization in specific territories.

Published Date: February 2024

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