Venatorx hopes FDA rejection of antibiotic combination will be short-lived
23 Feb 2024
License out/inDrug ApprovalQualified Infectious Disease Product
The FDA dealt a blow to Venatorx Pharmaceuticals and Melinta Therapeutics’ efforts to bring a new antibiotic combination to market for urinary tract infections after issuing a complete response letter (CRL). However, the companies are hoping for a quick response to the agency’s requests for further chemistry, manufacturing, and controls (CMC) data.
“While we are disappointed with this setback, we maintain utmost confidence in cefepime-taniborbactam,” said Christopher Burns, CEO of Venatorx. The antibiotic combination comprises the widely used beta-lactam cefepime with the investigational beta-lactamase inhibitor taniborbactam, previously known as VNRX-5133.
The application sought approval of cefepime-taniborbactam to treat adults with complicated urinary tract infections (cUTI), including acute pyelonephritis caused by susceptible gram-negative microorganisms. Along with CMC data, the FDA asked for information about the drug, testing methods and manufacturing process. However, Venatorx and Melinta noted that the regulator did not raise any efficacy or safety issues, and did not request further clinical studies.
“We are already hard at work generating the additional requested CMC data,” Burns said. The combination of cefepime and taniborbactam is also being investigated in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adults.
Last year, Venatorx entered into a deal with Melinta focused on commercialising cefepime-taniborbactam in the US. Meanwhile, Venatorx also has partnerships for the antibiotic combination with Everest Medicines in some parts of Asia, including China, and with Menarini for a number of other markets, including Europe and Latin America.
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