FDA Nixes Nabriva Antibiotic NDA on Inspection Findings

FDA has sent Nabriva Therapeutics a complete response letter on its NDA for Contepo (fosfomycin) injection for treating complicated urinary tract infections, including acute pyelonephritis. The letter cited issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers that must be resolved before FDA can approve the NDA, according to the company. The agency did not request any new clinical data and did not raise any safety concerns, it says.

Nabriva says fosfomycin for injection is a novel, first-in-class in the U.S., intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant strains. “Contepo utilizes a new dosing approach, originally developed by Zavante (which Nabriva Therapeutics acquired), to optimize its pharmacokinetics and pharmacodynamics,” it says.