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FDA grants priority review to cefepime-taniborbactam for complicated UTIs

News
Article

The new drug application is supported by findings from the phase 3 CERTAIN-1 trial.

The FDA has granted a priority review designation to a new drug application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor antibiotic for the treatment of patients with complicated urinary tract infections (cUTI), including acute pyelonephritis.1

"As multi-drug resistant [MDR] infections increasingly pose significant challenges to global public health, the FDA's acceptance of the NDA for priority review is a positive step toward review and potential approval of cefepime-taniborbactam, which was developed to address evolving critical unmet needs in [antimicrobial resistance],” said Rogers Yongqing Luo,

"As multi-drug resistant [MDR] infections increasingly pose significant challenges to global public health, the FDA's acceptance of the NDA for priority review is a positive step toward review and potential approval of cefepime-taniborbactam, which was developed to address evolving critical unmet needs in [antimicrobial resistance],” said Rogers Yongqing Luo,

The NDA is supported by findings from the phase 3 CERTAIN-1 trial,2 which evaluated the safety and efficacy of cefepime-taniborbactam compared with meropenem in patients with cUTI. Findings showed that cefepime-taniborbactam met the study’s primary efficacy end point by achieving a composite microbiologic and clinical success rate of 70.6%, compared with a rate of 50.8% observed among patients who received meropenem (treatment difference 12.6; 95% CI, 3.1 to 22.2). Efficacy of cefepime-taniborbactam was sustained for the late follow-up visit conducted from days 28 to 35.

"We congratulate our partner for achieving this important milestone and bringing cefepime-taniborbactam a step closer to reaching patients confronted with antibacterial resistant infections. As multi-drug resistant [MDR] infections increasingly pose significant challenges to global public health, the FDA's acceptance of the NDA for priority review is a positive step toward review and potential approval of cefepime-taniborbactam, which was developed to address evolving critical unmet needs in [antimicrobial resistance],” said Rogers Yongqing Luo, CEO of Everest Medicines, in a news release.1

“In Asia, the challenges we are facing from MDR infections are more urgent and severe. Everest is proud to be part of the global Phase 3 clinical study and is working closely with regulatory authorities and partner Venatorx to advance the drug candidate to NDA filings in China and other Asian territories as quickly as possible,” Luo added.

The FDA is scheduled to decide on the NDA on or before February 22, 2024.

Additional data from CERTAIN-1

The randomized, double-blind, active-controlled, non-inferiority phase 3 CERTAIN-1 study (NCT03840148)enrolled a total of 661 patients with acute pyelonephritis (42.2%) and other cUTIs (57.8%). Participants were randomly assigned to receive cefepime-taniborbactam 2.5g q8h or meropenem 1g q8h for 7 days, or up 14 days in patients with bacteremia, which was present in 13.1% of patients.The primary efficacy end point was the composite clinical and microbiologic response in the microbiological intent-to-treat population at the Test of Cure (TOC) visit (day 19-23).

Cefepime-taniborbactam met the primary end point and was found to be statistically superior to meropenem at the TOC visit (treatment difference 11.9%; 95% CI, 2.4 to 21.6; P = .0136). These findings were validated using a prespecified superiority assessment (2-sided P = .0088).

Additional findings showed that treatment-emergent adverse events (TEAEs) were experienced among 35.5% of patients who received cefepime-taniborbactam, compared with 29.0% of patients who received meropenem. Serious TEAEs were experienced by 2.0% of patients in the cefepime-taniborbactam arm, compared with 1.8% of patients in the meropenem arm.

In total, 3.0% of patients who received cefepime-taniborbactam discontinued treatment due to TEAEs, compared with 0.9% among patients who received meropenem.

References

1. Everest Medicines’ partner Venatorx receives FDA acceptance and priority review of new drug application for cefepime-taniborbactam to treat complicated urinary tract infections (cUTI). News release. Everest Medicines. August 15, 2023. Accessed August 15, 2023. https://www.prnewswire.com/news-releases/everest-medicines-partner-venatorx-receives-fda-acceptance-and-priority-review-of-new-drug-application-for-cefepime-taniborbactam-to-treat-complicated-urinary-tract-infections-cuti-301900949.html

2. McGovern PC, Wagenlehner F, Gasink L, et al. CERTAIN-1: A phase 3 study of cefepime-taniborbactam efficacy and safety in the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). Open Forum Infect Dis. Published online December 15, 2022. Accessed August 15, 2023. doi:10.1093/ofid/ofac492.022

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