Everest Medicines (HKEX 1952.HK)'s partner Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic for the potential treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis. The FDA has granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of Feb. 22, 2024.

"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 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 AMR," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "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."

The FDA previously granted Qualified Infectious Disease Product and Fast Track designations to cefepime-taniborbactam. The cefepime-taniborbactam NDA filing is supported by results from the pivotal Phase 3 study, CERTAIN-1, evaluating the efficacy and safety of cefepime-taniborbactam compared to meropenem in adults with cUTI, including acute pyelonephritis. Cefepime-taniborbactam was superior to meropenem for the primary efficacy endpoint of composite microbiologic and clinical success at the Test of Cure (TOC) visit (Day 19-23) in the microbiological intent-to-treat (microITT) population. Cefepime-taniborbactam was well-tolerated and no new safety findings were identified.

Infectious disease is one of Everest's key therapeutic areas, led by XERAVA® which was commercially launched in mainland China in July 2023. The company is also actively developing other important antibacterial drug candidates for combating the increasing MDR infections in China and the rest of Asia.