The FDA has accepted a new drug application and granted priority review status for fosfomycin for injection (Contepo, Nabriva Therapeutics plc) for the treatment of complicated urinary tract infections (cUTIs). The targeted date for completion of the review is June 30, 2019.
If fosfomycin is approved, it will be a first-in-class intravenous (IV) antibiotic with broad spectrum activity against Gram-negative and Gram-positive organisms, including ESBL-producing Enterobacteriaceae and other multi-drug resistant organisms. Annually, some three million cases of cUTIs require hospital treatment in the U.S. for Gram-negative infections.
A pivotal Phase 2/3 clinical trial (ZEUS™) met its primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients who had cUTIs, including acute pyelonephritis.
Each year, approximately 150 million UTIs occur worldwide, causing $6 billion in health care expenditures, according to the American Urological Association. Ineffective treatment can lead to an increase in treatment failure rates and re-hospitalization, infection recurrence, morbidity, and mortality.
IV fosfomycin has been used for over 45 years in Europe for a number of infections, including cUTIs. Contepo’s new dosing approach optimizes its pharmacokinetics and pharmacodynamics, strengthening the case for using the drug as a first-line treatment for cUTIs, including acute pyelonephritis. It is suspected that MDR pathogens are caused by acute pyelonephritis, and around 20% of cUTIs are caused by MDR bacteria. Currently, there are limited treatment options available in the U.S.
In addition to its priority review status, fosfomycin was granted qualified infectious disease product and fast track designations for the treatment of several serious infections, including cUTI.
Source: Drugs.com, January 4, 2018