Nabriva Therapeutics

Nabriva Therapeutics AG is a biopharmaceutical company dedicated to the discovery and development of antibiotics for community and hospital infections. The company focuses on the antibiotic class, and Lefamulin is the first pleuromutilin antibiotic for intravenous and oral administration in humans. We have completed two pivotal Phase 3 trials evaluating the safety and efficacy of treating community-acquired bacterial pneumonia (CABP), which is the leading cause of infectious death in the United States and the second most common reason for hospitalization. Lefamulin met all primary endpoints set by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in both the LEAP 1 and LEAP 2 trials, demonstrating overall good tolerability. Both formulations of Lefamulin received Qualified Infectious Disease Product and Fast Track designations from the FDA. On August 19, 2019, the FDA approved Xenleta® (Lefamulin) for both oral and intravenous use.