Nabriva Therapeutics announced that it received a Complete Response Letter (CRL) from the U.S. FDA for the New Drug Application resubmission seeking marketing approval of Contepo injection for the treatment of complicated urinary tract infections.
Contepo for injection is a novel, potentially first-in-class in the US, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity.
The FDA cited issues with Nabriva’s European contract manufacturing partners. Nabriva claims the issues could not be resolved due to FDA’s inability to conduct onsite inspections because of travel restrictions. According to the drugmaker's press release, "In general, previously identified product quality and facility inspection related observations at our contract manufacturing partners are required to be satisfactorily resolved before the NDA may be approved."
Nabriva had resubmitted its NDA to the FDA last December, based on the outcome of a Type A meeting with the agency which was conducted to obtain clarity on the CRL issued by the FDA in April 2019.
The drugmaker now plans to request a Type A meeting with the FDA to discuss appropriate next steps and the FDA’s plans for completing foreign facility inspections.
Read the press release