FDA accepts NDA for cefepime-taniborbactam for complicated UTIs

FDA accepts NDA for cefepime-taniborbactam for complicated UTIs | Image Credit: © wladimir1804 - © wladimir1804 - stock.adobe.com.

The FDA has accepted a New Drug Application (NDA) for cefepime-taniborbactam (VNRX-5133; Venatorx Pharmaceuticals) as treatment against complicated urinary tract infections (cUTIs) such as pyelonephritis in adults.

Cefepime-taniborbactam is an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic that has previously beengranted Qualified Infectious Disease Product and Fast Track designations. The recent NDA was accepted after a phase 3 study called CERTAIN-1 showed positive safety and efficacy results.

Cefepime is a fourth-generation cephalosporin with over 2 decades of data indicating safety and efficacy as a treatment against gram-negative and gram-positive bacteria.Taniborbactam is a BLI being studied in combination with cefepime as treatment against serious bacterial infections from gram-negative bacteria.

In the phase 3 trial, cefepime-taniborbactam was compared to meropenem in adults with cUTI. There were 661 adult patients enrolled in the trial, randomized 2:1 into a cefepime-taniborbactam 2.5g q8h or meropenem 1g q8h group. Treatment was administered for 7 days in most patients, though patients with bacteremia could receive treatment for up to 14 days.

The primary efficacy outcome was clinical success measured at the Test of Cure visit, which occurred between days 19 and 23 of treatment. This outcome was evaluated in the microbiological intent-to-treat population.

Greater efficacy was measured in patients taking cefepime-taniborbactam compared tomeropenem, with clinical success found in 70.6% of the cefepime-taniborbactam group and 58% of the meropenem group. Efficacy was also found in a late-follow-up visit after 28 to 35 days of treatment.

No additional safety findings were observed, andcefepime-taniborbactam was well-tolerated. Treatment-emergent adverse events (TEAEs) were seen in 35.5% of the cefepime-taniborbactam group and 29.0% of the meropenem group, while serious TEAEs were seen in 2% and 1.8% respectively.

Cefepime-taniborbactam, has been given a Prescription Drug User Fee Act date of February 22, 2024. If approved, it will provide a needed option for treating gram-negative bacterial infections.

Reference

Venatorx Pharmaceuticals announces FDA acceptance and priority review of New Drug Application for cefepime-taniborbactam to treat complicated urinary tract infections (cUTI), including pyelonephritis, in adults. Venatorx. August 15, 2023. Accessed August 15, 2023. https://www.venatorx.com/press-releases/venatorx-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-new-drug-application-for-cefepime-taniborbactam-to-treat-complicated-urinary-tract-infections-cuti-including-pyelonephritis/