The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Nabriva Therapeutics regarding the New Drug Application (NDA) for Contepo (fosfomycin for injection). The CRL requests that the Company address issues concerning facility inspections and manufacturing deficiencies.
Contepo, an investigational epoxide intravenous antibiotic, has broad spectrum activity against Gram-negative and Gram-positive pathogens, including multi-drug resistant strains such as ESBL-producing Enterobacteriaceae. In November 2018, the Company submitted the NDA for Contepo seeking approval as a treatment for complicated urinary tract infections, including acute pyelonephritis. The NDA included data from the ZEUS trial which demonstrated statistical non-inferiority of Contepo to piperacillin/tazobactam.
The CRL directs the Company to address facility inspections and manufacturing deficiencies at one of their contract manufacturers, before any approval can occur. There was no request for new clinical data and no issues over safety were raised.
CEO of Nabriva, Ted Schroeder said, “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.”
For more information visit Nabriva.com.