24 June 2019 - Nabriva Therapeutics today announced that the EMA has determined that the company’s marketing authorisation application for 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, is valid.

Nabriva also has a new drug applications for lefamulin under review by the U.S. FDA with an assigned Prescription Drug User Fee Act action date of 19 August 2019 for both the IV and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia.

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