Nabriva Therapeutics announced the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its New Drug Application (NDA) resubmission for marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs).
In the acknowledgement letter for the resubmitted NDA, the FDA stated that Nabriva’s filing was a complete, class 2 response to the complete response letter the FDA issued on April 30, 2019. As a result, the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of June 19, 2020 for the completion of its review of the NDA.
CONTEPO is a potential first-in-class intravenous antibiotic in the U.S. for the treatment of cUTIs. The NDA resubmission is supported by data from 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.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
Complicated urinary tract infection (cUTI) occurs when Gram-negative bacteria are embedded in the bladder wall where they can multiply more slowly and are much harder to address with antibiotics. Patients who are being treated for a urinary tract infection and fail to respond to an initial course of antibiotics can go on to develop a cUTI.
Among the causes of cUTI is Enterobacteriaceae, which is a multi-drug resistance (MDR) strain of Gram-negative bacteria. Enterobacteriaceae produces extended spectrum beta-lactamases (ESBL), a chemical that can cause some antibiotics to be ineffective in treating bacterial infections such as cUTI. As a result, cUTI poses a serious and rapidly emerging health threat for hospitalized patients, especially those in intensive care units.
CONTEPO (fosfomycin) for injection is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as extended spectrum β-lactamase (ESBL)-producing Enterobacteriaceae. IV fosfomycin has been approved for a number of indications and utilized for over 45 years outside the U.S. to treat a variety of infections, including cUTIs and other serious bacterial infections.