Nabriva Asks Type A Meeting at FDA for Intravenous UTI Med

Nabriva Therapeutics plc (NBRV), a clinical-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced today that it has submitted a Type A Meeting Request and Briefing Document to the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated April 30, 2019 for the New Drug Application (NDA) seeking marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

As 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, the purpose of the meeting is to discuss and gain clarity on the issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers that were described in the CRL and other matters pertaining to the steps required for the resubmission of the NDA for CONTEPO. The Type A meeting, per regulation, is required to occur within thirty days of FDA’s receipt of the meeting request.

The company will provide an update on the timing of resubmission of the NDA for CONTEPO after receipt of the FDA’s final meeting minutes, which should occur within thirty days after the date of the Type A Meeting.

https://finance.yahoo.com/news/nabriva-therapeutics-submits-type-meeting-110000586.html