BC 3781 filed with FDA for community-acquired bacterial pneumonia.- Nabriva Therapeutics.

Nabriva Therapeutics announced the submission of two New Drug Applications (NDAs) to the FDA for the oral and intravenous (IV) formulations of BC 3781 (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 two NDAs are supported by two pivotal, Phase III 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.