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 for the treatment of community-acquired bacterial pneumonia (CABP), the leading cause of infection death and the second most common cause of hospitalization in the United States. Lefamulin met all U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)primary endpoints in both LEAP 1 and LEAP 2 and was shown to be generally well tolerated. In February 2019, these applications were accepted by the FDA, granted priority review and given a PDUFA date of August 19, 2019. Both formulations of lefamulin were granted Qualified Infectious Disease Product and Fast Track designation by the FDA. In May 2019, we submitted a marketing authorization application for both the IV and oral formulations of lefamulin, for the treatment of community-acquired pneumonia (CAP) in adults 18 years of age and older, to the EMA. If approved, Nabriva intends to work with a commercial partner to make lefamulin available to patients in the European Union. On August 19, 2019, the FDA Approved Xenleta™(lefamulin) for both Oral And IV use.
Through our research and development efforts, we have also identified a topical pleuromutilin product candidate, BC-7013, for which we have completed a Phase 1 clinical trial. We believe that this pleuromutilin compound is well suited for the topical treatment of a variety of Gram-positive infections, including uncomplicated skin and skin structure infections.
CONTEPO™ (fosfomycin for injection) is a potentially first-in-class epoxide intravenous (“IV”) antibiotic in the United States with a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against many contemporary multi-drug resistant (“MDR”) strains that threaten hospitalized patients. IV fosfomycin has an extensive commercial history in markets outside the United States, where it has been used broadly for over 45 years to treat a variety of indications, including complicated urinary tract infections, bacteremia, pneumonia and skin infections. In October 2018, Nabriva Therapeutics submitted a New Drug Application (NDA) to the FDA to seek marketing approval for CONTEPO™ to treat cUTIs, including acute pyelonephritis. On April 30, 2019, we received a Complete Response Letter (CRL) from the FDA for the NDA. The CRL requests that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers prior to the FDA approving the NDA. In December 2019, Nabriva resubmitted its New Drug Application (NDA) to the FDA for CONTEPO™ (fosfomycin) for injection for the treatment of complicted urinary tract infections(cUTIs), including acture pyelonephritis. Nabriva anticipates a six-month review period by the FDA.