Priority Review for Venatorx UTI Drug NDA

FDA has accepted and will give priority review to a Venatorx Pharmaceuticals NDA for cefepime-taniborbactam to treat complicated urinary tract infections (cUTI), including pyelonephritis, in adults. The company says the agency set 2/22/2024 as the PDUFA action date for the NDA.

It says the NDA is supported by results from the pivotal Phase 3 CERTAIN-1 study that evaluated the efficacy and safety of cefepime-taniborbactam compared to meropenem (Pfizer’s Merrem) in adults with cUTI, including acute pyelonephritis. Venatorx says cefepime-taniborbactam was superior to Merrem for the primary efficacy endpoint and was well-tolerated with no new safety findings.

Cefepime-taniborbactam is described as an investigational intravenous beta-tactam/beta-tactamase inhibitor antibiotic combination being developed to treat cUTIs and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.