FDA Approves Antibiotic for Community-Acquired Pneumonia

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 that patients treated with Xenleta had similar rates of clinical success as those treated with the antibiotic, moxifloxacin with or without linezolid.  
 
"This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease," said Ed Cox, M.D., M.P.H., director of FDA's Office of Antimicrobial Products. "For managing this serious disease, it is important for physicians and patients to have treatment options. This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics."

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