Nabriva Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has approved Nabriva’s Xenleta (lefamulin) for community-acquired bacterial pneumonia (CABP) in adult patients. The drug is available in both oral and IV dosage forms.
The oral dosage form is available in 600 mg strength, which can be administered every 12 hours and IV in 150 mg which should be administered every 12 hours. The company estimated that the US is spending approximately $17 billion in hospital admission for patients with pneumonia, which can be reduced with the approval of Xenleta.
The company claimed that this is the first drug in the two decades with the novel mechanism of action.
Both the IV and oral formulations of Xenleta granted Qualified Infectious Diseases Product (QIDP) and Fast Track Designation. The approval is based on LEAP 1 and LEAP 2 study, which evaluated the safety and efficacy of IV and oral dosage forms. Xenleta was compared with moxifloxacin. In LEAP 1 study, Xenleta IV/oral dosage form was compared with moxifloxacin, in LEAP 2 study, Xenleta oral dosage form is compared with moxifloxacin oral dosage form. In both the studies, the drug has similar efficacy as moxifloxacin.
The drug was well tolerated in both the trials.
The drug is expected to be available in the United States from mid-September.