FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Approves Xenleta for Community-Acquired Bacteria Pneumonia

Aug. 23, 2019
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Nabriva Therapeutics won FDA approval for Xenleta (lefamulin) to treat community-acquired bacterial pneumonia (CBAP).

Available as an oral tablet and an intravenous  formula, the antibiotic is used to treat adult patients with CBAP, a pneumonia infection acquired outside of hospital and healthcare settings.

The drug’s approval was based on the results of two clinical trials which compared treatment with Xenleta to treatment with moxifloxacin in a total of 1,289 patients. The results showed that patients treated with Xenleta had similar rates of clinical success as those treated with moxifloxacin.

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