Posted by Michael Wonder on 09 May 2019
Nabriva Therapeutics announces submission of marketing authorisation application for lefamulin to treat community-acquired pneumonia in adults by European Medicines Agency
8 May 2019 - Nabriva Therapeutics announced that the Company’s marketing authorisation application for both the intravenous and oral formulations of lefamulin, a potentially first-in-class, semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired pneumonia in adults 18 years of age and older, has been submitted to the European Medicines Agency
If approved, Nabriva intends to work with a commercial partner to make lefamulin available to patients in the EU.
The MAA filing is supported by two pivotal, Phase 3 clinical trials (known as LEAP 1 and LEAP 2) that evaluated the safety and efficacy of intravenous and oral lefamulin compared to moxifloxacin in the treatment of adults with community-acquired pneumonia.
