China's NMPA Recommends Priority Review for Cefepime-Taniborbactam in UTI Treatment

20 September 2023 | Wednesday | News


Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing, manufacturing, and commercializing transformative pharmaceutical products and vaccines in Greater China and other parts of Asia, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review for cefepime-taniborbactam for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, based on the criteria of "innovative drugs for the prevention and treatment of major infectious diseases and rare diseases that meet urgent clinical needs."
Image Source : Public Domain

Image Source : Public Domain

"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.

News

Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox

Show

Forgot your password?

Show

Show

Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in

Close