Nabriva Therapeutics has resubmitted the New Drug Application (NDA) for Contepo (fosfomycin for injection) for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis.
Fosfomycin is a novel, epoxide intravenous antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against multi-drug resistant (MDR) strains such as extended spectrum β-lactamase (ESBL)-producing Enterobacteriaceae. Compared with other injectable antibiotics, Contepo works by inhibiting cell wall formation at an early stage in cell wall synthesis.
Earlier this year, the Food and Drug Administration issued a Complete Response Letter (CRL) regarding an initial NDA for fosfomycin. The CRL directed the Company to address facility inspections and manufacturing deficiencies at 1 of their contract manufacturers, however, no request was made for new clinical data and no issues over safety were raised.
“We are pleased to have received input from the FDA on the required information to include in the Contepo NDA resubmission to address the CRL,” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. “We look forward to continuing to work with the FDA to bring this important treatment option to patients in the United States.”
For more information visit nabriva.com.