{"id":15113,"date":"2023-08-16T00:13:00","date_gmt":"2023-08-15T16:13:00","guid":{"rendered":"https:\/\/flcube.com\/?p=15113"},"modified":"2024-11-27T00:18:35","modified_gmt":"2024-11-26T16:18:35","slug":"everest-medicines-partner-venatorx-pharmaceuticals-receives-fda-priority-review-for-cefepime-taniborbactam","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15113","title":{"rendered":"Everest Medicines’ Partner Venatorx Pharmaceuticals Receives FDA Priority Review for Cefepime-Taniborbactam"},"content":{"rendered":"\n

China-based Everest Medicines (HKG: 1952<\/a>) announced that its partner, Venatorx Pharmaceuticals, has received acceptance from the US Food and Drug Administration (FDA) for a New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam\/beta-lactamase inhibitor (BL\/BLI) antibiotic. The drug is intended for the potential treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis. The FDA has granted the NDA Priority Review status, with a Prescription Drug User Fee Act (PDUFA) target action date set for February 22, 2024.<\/p>\n\n\n\n

Everest Medicines’ Licensing Deal with Venatorx<\/strong>
Venatorx Pharmaceuticals entered into a licensing agreement with Everest Medicines in September 2018, which granted Everest the rights to develop and commercialize cefepime-taniborbactam in Greater China, South Korea, and select South-East Asian countries.<\/p>\n\n\n\n

Supporting Data for FDA Filing and Efficacy Results<\/strong>
The FDA filing is supported by the results from the pivotal Phase III CERTAIN-1 study, which evaluated the efficacy and safety of cefepime-taniborbactam compared to meropenem in adults with cUTI, including acute pyelonephritis. Cefepime-taniborbactam demonstrated superiority 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. The drug was well-tolerated, and no new safety findings were identified.<\/p>\n\n\n\n

Everest Medicines’ Focus on Infectious Disease Therapies<\/strong>
Infectious disease is a key therapeutic area for Everest Medicines, led by Xerava, which was commercially launched in mainland China in July 2023. The company is actively developing other important antibacterial drug candidates to combat the increasing threat of multidrug-resistant (MDR) infections in China and the rest of Asia.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Everest Medicines (HKG: 1952) announced that its partner, Venatorx Pharmaceuticals, has received acceptance from…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[126,1164,2377],"class_list":["post-15113","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-everest-medicines","tag-hkg-1952","tag-venatorx-pharmaceuticals"],"yoast_head":"\nEverest Medicines' Partner Venatorx Pharmaceuticals Receives FDA Priority Review for Cefepime-Taniborbactam - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Everest Medicines (HKG: 1952) announced that its partner, Venatorx Pharmaceuticals, has received acceptance from the US Food and Drug Administration (FDA) for a New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam\/beta-lactamase inhibitor (BL\/BLI) antibiotic. The drug is intended for the potential treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis. The FDA has granted the NDA Priority Review status, with a Prescription Drug User Fee Act (PDUFA) target action date set for February 22, 2024.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=15113\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Everest Medicines' Partner Venatorx Pharmaceuticals Receives FDA Priority Review for Cefepime-Taniborbactam\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. 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