Nabriva Therapeutics has received a Complete Response Letter from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) of its intravenous Contepo (fosfomycin) injection.
The company cited issues related to facility inspections and manufacturing deficiencies at one contract manufacturer, meaning that the injection for the treatment of complicated urinary tract infections was rejected.
The letter requests that Nabriva address the issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers prior to the FDA approving the NDA.
The company plans to request a “Type A” meeting to discuss the FDA’s findings, but the governing body did not request any new clinical data and did not raise any concerns with regard to the safety of Contepo.
“We will be working with the FDA in the coming weeks to gain a full understanding of the FDA’s comments, with the goal of bringing this important treatment to patients as quickly as possible,” said Ted Schroeder, chief executive officer of Nabriva Therapeutics.
The drug - previously referred to as ZTI-01 and ZOLYD - 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 ESBL-producing Enterobacteriaceae.
An estimated 40% of complicated urinary tract infections are suspected to be caused by MDR bacteria and limited treatment options are available in the U.S. for these patients.