The FDA has approved lefamulin (Xenleta, Nabriva Therapeutics) to treat adults with community-acquired bacterial pneumonia (CABP). Xenleta is marketed by Nabriva Therapeutics.
According to data from the Centers for 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.
In two clinical trials with 1,289 patients with CABP, lefamulin was compared to moxifloxacin with or without linezolid. Patients in both groups had similar rates of clinical success.
The most common adverse reactions reported in patients taking lefamulin included diarrhea, nausea, injection-site reactions (lefamulin can also be given orally), elevated liver enzymes, and vomiting. Lefamulin has the potential to cause a prolonged QT interval. Patients who have prolonged QT interval or arrhythmias, or who are receiving antiarrhythmic agents or other drugs that prolong the QT interval should avoid lefamulin.
In addition, this agent should not be used in patients with known hypersensitivity to lefamulin or any other members of the pleuromutilin antibiotic class, or to any of lefamulin’s components. Based on findings of fetal harm in animal studies, pregnant women and women who could become pregnant should be advised of lefamulin’s potential risks to a fetus. Women who could become pregnant should be advised to use effective contraception during treatment with lefamulin and for two days after the final dose.
The FDA granted lefamulin qualified infectious disease product and priority review designations.
Source: FDA, August 19, 2019