1 November 2018 - Nabriva Therapeutics announced it has submitted a new drug application to the U.S. FDA to seek marketing approval for its investigational intravenous antibiotic, Contepo (fosfomycin for injection) to treat complicated urinary tract infections, including acute pyelonephritis. 

Contepo has been granted qualified infectious disease product and fast track designations by the FDA for the treatment of several serious infections, including complicated urinary tract infection, which enables priority review of the NDA, following acceptance.

The NDA submission is utilising the 505(b)(2) regulatory pathway and is supported by a robust data package, including a pivotal Phase 2/3 clinical trial (known as ZEUS), which met its primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with cUTI, including acute pyelonephritis.

Read Nabriva Therapeutics press release