Officials with the FDA today approved lefamulin (Xenleta, Nabriva Therapeutics) to treat adults with community-acquired bacterial pneumonia (CABP).1,2 It is the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly 2 decades, according to Nabriva.1

“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” said Ed Cox, MD, MPH, director of FDA’s Office of Antimicrobial Products, in a prepared statement.2 “For managing this serious disease, it is important for physicians and patients to have treatment options.”

According to CDC, about 1 million people are hospitalized with pneumonia and 50,000 people die from the disease each year in the United States.3

Nabriva’s lefamulin is available for oral (600 mg every 12 hours) and IV (150 mg every 12 hours) administration with a short 5-to-7 day course of therapy. Clinicians can initiate patients on IV or oral therapy, allowing for potential avoidance of hospitalization, or can transition from IV to oral therapy, which may expedite discharge from the hospital, according to the company.1 

The safety and efficacy of lefamulin, taken either orally or intravenously, was evaluated in 2 clinical trials with a total of 1289 patients with CABP. In these trials, treatment with lefamulin was compared to another antibiotic, moxifloxacin with or without linezolid. The trials showed that patients treated with lefamulin had similar rates of clinical success as those treated with moxifloxacin with or without linezolid.2 

The most common adverse reactions reported in patients taking lefamulin included diarrhea, nausea, reactions at the injection site, elevated liver enzymes and vomiting. Lefamulin has the potential to cause a change on an ECG reading, and patients with prolonged QT interval, patients with certain irregular heart rhythms, patients receiving treatment for antiarrhythmic agents, and patients receiving other drugs that prolong the QT interval should avoid this drug. 2

In addition, lefamulin should not be used in patients with known hypersensitivity to the drug or any other members of the pleuromutilin antibiotic class, or any of the components of lefamulin. Based on findings of fetal harm in animal studies, pregnant women and women who could become pregnant should be advised of the potential risks of lefamulin to a fetus. Women who could become pregnant should be advised to use effective contraception during treatment with the drug and for 2 days after the final dose. 2

Nabriva Therapeutics obtained the FDA’s Qualified Infectious Disease Product (QIDP) designation,1.2 which is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, for lefamulin. As part of QIDP designation, lefamulin also was granted Priority Review status by the FDA.2

  1. Nabriva Therapeutics Receives U.S. FDA Approval of Xenleta™ (lefamulin) to Treat Community-Acquired Bacteria Pneumonia (CABP) [news release]. Dublin, Ireland; August 19, 2019: Nabriva website. Accessed August 19, 2019.
  2. FDA approves new antibiotic to treat community-acquired bacterial pneumonia [news release]. Silver Spring, MD; August 19, 2019: FDA website. Accessed August 19, 2019. 
  3. Centers for Disease Control and Prevention. Pneumonia: Pneumonia Can Be Prevented—Vaccines Can Help. CDC website. Reviewed October 18, 2018. Accessed August 19, 2019.