Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced the submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for the oral and intravenous (IV) formulations of lefamulin, a first-in-class, semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired bacterial pneumonia (CABP). Both formulations of lefamulin were granted Qualified Infectious Disease Product and Fast Track designation by the FDA, enabling potential Priority Review of the NDAs by the FDA. Nabriva Therapeutics plans to submit a marketing authorization application for lefamulin in Europe in the first quarter of 2019.
“The submission of the lefamulin NDAs marks another major milestone for Nabriva Therapeutics, demonstrating our commitment to develop novel anti-infective agents that address the urgent, unmet medical need faced by patients with serious infections,” said Dr. Jennifer Schranz, chief medical officer of Nabriva Therapeutics. “Together with our CONTEPO™ NDA submission, we are one-step closer to offering US clinicians two, novel, first-in-class antibiotics. We believe lefamulin has the potential to provide a much-needed monotherapy treatment option for adults with CABP in both the hospital and ambulatory care settings. We are grateful to the patients and investigative sites who have supported the development of lefamulin for treatment of CABP.”
The two NDAs are supported by two pivotal, Phase 3 clinical trials (known as LEAP 1 and LEAP 2) that evaluated the safety and efficacy of IV and oral lefamulin compared to moxifloxacin in the treatment of adults with CABP, including the option to switch from IV to oral administration and a short course oral treatment with lefamulin. In both LEAP 1 and LEAP 2, lefamulin was demonstrated to be non-inferior to moxifloxacin, and met both the FDA and European Medicines Agency (EMA) primary and secondary efficacy endpoints for the treatment of CABP. Lefamulin was also shown to be generally well-tolerated when administered either orally or intravenously.
