Skip to NavigationSkip to content

FDA refuses to review Nabriva's injectable antibiotic for urinary tract infections

Published on 01/05/19 at 10:51am

Biopharma firm Nabriva Therapeutics has revealed that its antibiotic Contepo (fosfomycin) has been rejected for review by the FDA as an injectable treatment for complicated urinary tract infections (cUTI), including acute pyelonephritis.

According to the manufacturer, Contepo is the first intravenously administered epoxide therapy in the US.

The company received a complete response letter (CRL) from the US regulator, outlining issues relating to one of Nabriva’s contract manufacturing facilities, identified during a recent inspection. No additional clinical data was requested, and the safety of the drug was not brought into question.

Nabriva has said that it intends to request a ‘Type A’ meeting with the FDA to discuss the raised issues.

“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.

Antibiotic resistance is leading to around two million serious infections per year in the US alone, while almost 23,000 deaths as a result.

Matt Fellows

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches