Contepo filed with FDA for complicated urinary tract infections.- Nabriva Therapeutics.

Nabriva Therapeutics has submitted a New Drug Application (NDA) to the FDA to seek marketing approval for its investigational intravenous antibiotic, Contepo (fosfomycin for injection) to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis. Contepo has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of several serious infections, including cUTI, which enables Priority Review of the NDA, following acceptance.

Contepo is a first-in-class injectable epoxide antibiotic with a differentiated mechanism of action and broad spectrum of activity against Gram-negative and Gram-positive pathogens, including multi-drug resistant (MDR) pathogens.