FDA provides complete response letter for resubmission of Contepo in complicated urinary tract infections.- Nabriva Therapeutics

Nabriva Therapeutics has received a Complete Response Letter from the FDA for the New Drug Application (NDA) resubmission seeking marketing approval of Contepo (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. Although Nabriva’s European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at our manufacturing partners that could not be resolved due to FDA’s inability to conduct onsite inspections because of travel restrictions. 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. The FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of Contepo in the CRL.

Nabriva 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. Contepo has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of serious infections, including cUTI.

In May 2019, the company received a Complete Response Letter from the FDA for the New Drug Application requesting that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers prior to the FDA approving the NDA.