Public health agency the US Food and Drug Administration announced on Monday that it has approved the new antibiotic Xenleta (lefamulin) for the treatment of adults with community-acquired bacterial pneumonia under its Qualified Infectious Disease Product (QIDP) designation.

The agency granted the approval of Xenleta to Nabriva Therapeutics.

Community-acquired pneumonia occurs when someone develops pneumonia in the community (not in a hospital). Pneumonia is a type of lung infection that can range in severity from mild to severe illness and can affect people of all ages.

In conjunction, the safety and efficacy of the company's Xenleta, taken either orally or intravenously, was evaluated in two clinical trials with a total of 1,289 patients with CABP.

In both the trials, the treatment with the company's Xenleta was compared to another antibiotic, moxifloxacin with or without linezolid. The patients treated with Xenleta had similar rates of clinical success as those treated with moxifloxacin with or without linezolid.