Nabriva Therapeutics PLC has submitted its antibiotic treatment for a type of bacterial pneumonia to the U.S. Food and Drug Administration for approval.
Ireland-based Nabriva said in a Dec. 20 press release that a new drug application for the oral and intravenous formulations of lefamulin has been submitted to the U.S. regulator to treat community-acquired bacterial pneumonia. Both formulations of the antibiotic have been granted qualified infectious disease product and fast track designation by the FDA, which means the medicine could be up for a priority review.
Community-acquired bacterial pneumonia affects more than 5 million adults a year in the U.S., according to data analyzed by Nabriva.
The FDA submission is supported by phase 3 clinical trials that evaluated lefamulin compared to moxifloxacin, a common antibiotic treatment for pneumonia. The trial showed that lefamulin is similarly effective to moxifloxacin.
The company will also seek marketing authorization for lefamulin in the EU, with plans to submit its application in the first quarter of 2019.
Nabriva is a clinical-stage biopharmaceutical company that develops anti-infective agents to treat infections in humans.