Nabriva evaluated the drug, available in oral or intravenous formulations, in two clinical trials with 1,289 community-acquired pneumonia patients. Researchers found the drug worked just as well as another antibiotic, moxifloxacin, in treating the disease.
Some patients had altered electrocardiogram readings after taking Xenleta . The FDA advises against Xenleta for patients with conditions including heart arrhythmias. The drug may also pose a threat to fetuses and is therefore not suitable for pregnant women.
Approval of Xenleta offers pneumonia patients more treatment options, which the FDA says is crucial in addressing the threat of antimicrobial resistance.
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