Posted by Michael Wonder on 21 Dec 2018
Nabriva Therapeutics submits new drug applications to U.S. FDA for intravenous and oral lefamulin to treat community-acquired bacterial pneumonia in adults
20 December 2018 - Nabriva Therapeutics announced the submission of two new drug applications to the U.S. FDA for the oral and intravenous formulations of lefamulin, a first-in-class, semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired bacterial pneumonia.
Both formulations of lefamulin were granted qualified infectious disease product and fast track designation by the FDA, enabling potential priority review of the applications by the FDA. Nabriva Therapeutics plans to submit a marketing authorisation application for lefamulin in Europe in the first quarter of 2019.
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 community-acquired bacterial pneumonia, including the option to switch from IV to oral administration and a short course oral treatment with lefamulin.
