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New Antibiotic Approved by FDA


August 19, 2019

The FDA has approved an antibiotic for the treatment of community-acquired bacterial pneumonia in adult patients.  

“According to data from the Centers from Disease Control and Prevention, each year in the United States, about one million people are hospitalized with community-acquired pneumonia and 50,000 people die from the disease,” the FDA explained in a press release. 

The newly approved drug, Xenleta (lefamulin; Nabriva Therapeutics), can be taken orally or intravenously, and the safety and efficacy were evaluated in 2 clinical trials. The trials included 1289 patients with community-acquired bacterial pneumonia. Researchers of these trials compared Xenleta to moxifloxacin with or without linezolid.  

The trials showed that patients treated with Xenleta had similar rates of clinical success as those treated with moxifloxacin with or without linezolid.”

According to the trial outcomes, the most common adverse reactions included diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. The FDA noted that Xenleta “should not be used in patients with known hypersensitivity to lefamulin or any other members of the pleuromutilin antibiotic class, or any of the components of Xenleta.” Additionally, pregnant women and women who could become pregnant should be advised of the potential risks of this treatment to a fetus.  

“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” Ed Cox, MD, MPH, director of FDA’s Office of Antimicrobial Products, said in a statement. “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.” 

Julie Gould  

Reference:

The US Food and Drug Administration. FDA approves new antibiotioc to treat community-acquired bacterial pneumonia [press release].  https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-treat-community-acquired-bacterial-pneumonia. FDA website. August 19, 2019.

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