20 September 2023 | Wednesday | News
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"Currently, the clinical challenges from multi-drug resistant infections are severe. The recommendation of priority review by CDE for cefepime-taniborbactam underscores the important clinical value of the medicine. It shows that cefepime-taniborbactam has a clinical advantage to address urgent and unmet medical needs in China. We will work closely with the Regulatory Agency to bring this innovative medicine to Chinese patients as quickly as possible," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Our leading product in the infectious disease space XERAVA® has commercially launched in China. Cefepime-taniborbactam will strengthen Everest's infectious disease portfolio, which is a key therapeutic area that will help drive our future growth."
Our partner Venatorx Pharmaceuticals announced in August that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for cefepime-taniborbactam and granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of Feb. 22, 2024. The cefepime-taniborbactam NDA filing was 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.