The U.S. Food and Drug Administration has approved Nabriva Therapeutics PLC's antibiotic Xenleta to treat a type of bacterial pneumonia.
Xenleta is also known as lefamulin. It will be available in both intravenous and oral formulations to treat community-acquired bacterial pneumonia, an infection in which the tiny air sacs, or alveoli, inside the lungs fill up with fluid.
Each year in the U.S., about 1 million people are hospitalized with bacterial pneumonia and 50,000 patients die, according to data from the Centers from Disease Control and Prevention.
The U.S. regulator granted Xenleta qualified infectious disease product designation and conducted a priority review of Nabriva's application.
The approval is based on results from two phase 3 studies, Leap 1 and Leap 2. Moxifloxacin, also marketed as Avelox by Bayer AG, is an antibiotic used to treat various bacterial infections and is part of the World Health Organization's list of essential medicines.
Xenleta was found to be as effective as moxifloxacin and its combination with linezolid during the Leap 1 trial. In the Leap 2 trial, oral Xenalta sustained its efficacy to oral moxifloxacin despite its dosing regimen being two days less.
The Ireland-based pharmaceuticals company expects to make the drug available in the U.S. in mid-September. It set the wholesale price of Xenleta at $205 per IV patient treatment day and $275 per oral patient treatment day.
The European Medicines Agency accepted Nabriva's marketing application for Xenleta to treat community-acquired bacterial pneumonia in June. The agency's Committee for Medicinal Products for Human Use is expected to complete its review and deliver a decision on the company's application in the next 12 to 15 months.
