Nabriva Therapeutics PLC – ADR (NASDAQ:NBRV) recently announced that it received the Food and Drug Administration’s (FDA) complete response letter regarding its New Drug Application submission for CONTEMPO.
The biopharma resubmitted the NDA application for CONTEMPO seeking its use as a treatment for complicated urinary tract infections (cUTI) such as pyelonephritis. The company revealed that the FDA could not conduct on-site inspections of facilities where the treatment is to be manufactured because of the current travel bans. This is even though the company’s European contract manufacturing partners were already prepared for the inspection.’
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The FDA letter addressed the travel ban implemented to prevent the coronavirus spread as the major issue standing in the way of the FDA infection. The U.S regulator has to inspect the production facility and also the product quality before issuing an NDA approval.
“In general, previously identified product quality and facility inspection related observations at our contract manufacturing partners are required to be satisfactorily resolved before the (new drug application) may be approved,” stated Nabriva in a press release.
Also worth noting is that the FDA’s response letter did not feature a request for additional data to support the NDA application. It also did not raise any concerns about the safety and efficacy data collected from previous clinical studies.
What is Nabriva’s next course of action?
Nabriva revealed that it plans to set up a Type A meeting with the FDA to discuss the best course of direction moving forward. This will include plans for inspecting the production facilities sometime soon. The company believes that the inspections will yield positive findings, which will advance the treatment to the next step.
The FDA had originally inspected Nabrivia’s contract manufacturer, and the verdict was that there were some manufacturing and inspection deficiencies. However, Nabrivia stated that it did not receive any warning letter about anything that may have resulted in the less than favorable findings from the initial inspection. The company expects CONTEMPO to be its next drug to receive the FDA’s approval after Xenleta, which received regulatory greenlight in 2019.