Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Intravenous CONTEPO™ (fosfomycin) for injection
8:16 pm ET April 30, 2019
Issues related to facility inspections and manufacturing deficiencies at one contract manufacturer
Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) 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.
The CRL requests 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. Nabriva plans to request a “Type A” meeting to discuss the FDA’s findings. The FDA did not request any new clinical data and did not raise any concerns with regard to the safety of CONTEPO.
“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,” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics.
Conference Call and Webcast
Nabriva Therapeutics will host a conference call and webcast at 8:00 a.m. EDT tomorrow, May 1, 2019. The live webcast can be accessed under “Events and Presentations” in the Investors section of Nabriva Therapeutics’ website at www.nabriva.com and will be accessible for 90 days. The conference call can also be accessed by dialing (866) 811-8671 (U.S./Canada) or (409) 981-0874 (international) and providing the passcode 8537966.
