FDA Approves Antibiotic for Community-Acquired Pneumonia

Patients treated with Xenleta had similar rates of clinical success as those treated with moxifloxacin with or without linezolid

The U.S. Food and Drug Administration granted the approval of Xenleta (lefamulin) to Nabriva Therapeutics for the treatment community-acquired bacterial pneumonia in adults. Xenleta received the FDA’s Qualified Infectious Disease Product (QIDP) designation and was granted Priority Review.    The safety and efficacy of Xenleta, taken either orally or intravenously, was evaluated in two clinical trials where Xenleta was compared to moxifloxacin with or without linezolid. The trials showed ...

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