Manufacturing issues have led the US Food and Drug Administration (FDA) to reject a New Drug Application (NDA) for cefepime-taniborbactam, a combination antibiotic under review as a potential treatment for urinary tract infections (UTIs) caused by multidrug-resistant bacteria.
In a press release late last week, Venatorx Pharmaceutical and Melinta Therapeutics said the FDA issued a Complete Response Letter to the NDA requesting additional chemistry, manufacturing, and controls (CMC) and related data about the drug, testing methods, and manufacturing process. The companies said the FDA did not identify clinical safety or efficacy issues, nor did it request any new clinical trials.
Developed by Venatorx, of Malvern, Pennsylvania, cefepime-taniborbactam combines a fourth-generation cephalosporin antibiotic with a beta-lactamase inhibitor. The results of a phase 3 trial recently published in the New England Journal of Medicine found the combination antibiotic was superior to meropenem in patients with complicated UTIs. Venatorx submitted the NDA to the FDA in August 2023 based on the results of that trial.
The drug is also viewed as a potential treatment for other infections caused by drug-resistant gram-negative bacteria and other organisms. In October 2022, Venatorx received a $318 million contract from the Biomedical Advanced Research and Development Authority to develop cefepime-taniborbactam for treating melioidosis, a respiratory disease caused by the bacterium Burkholderia pseudomallei.
Company says it will work with FDA
"While we are disappointed with this setback, we maintain utmost confidence in cefepime-taniborbactam," said Venatorx CEO Christopher J. Burns, PhD. "We are already hard at work generating the additional requested CMC data, and we will continue to work closely with the FDA so that we can make this important new medicine available to patients as quickly as possible."
Venatorx and Melinta, of Parsippany, New Jersey, announced a partnership in November 2023 to commercialize cefepime-taniborbactam in the United States.
"We are committed to our plans of supporting the US commercialization of this drug, which we believe when approved, will offer healthcare providers an important therapy for adult patients suffering from complicated urinary tract infections, including acute pyelonephritis caused by susceptible gram-negative microorganisms," Melinta CEO and President Christine Ann Miller, MBA, said.