For immediate release:
August 19, 2019

The US Food and Drug Administration today approved Xenleta (lefamulin) to treat adults with bacterial pneumonia acquired in the community.

"This new drug offers 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 the Bureau of Antimicrobial Products at the FDA. "To manage this serious illness, it is important that doctors and patients have treatment options. This approval reinforces our ongoing commitment to treating the treatment of infectious diseases by facilitating the development of new antibiotics. "

Community-acquired pneumonia occurs when someone develops pneumonia in the community (not in a hospital). Pneumonia is a type of lung infection that ranges in severity from mild to severe and can affect people of all ages. According to data from the Centers for Disease Control and Prevention, every year in the United States, about one million people are hospitalized for community-acquired pneumonia and 50,000 people die from it.

The safety and efficacy of Xenleta, taken orally or intravenously, has been evaluated in two clinical trials involving 1,289 patients with CAPR. In these trials, treatment with Xenleta was compared with another antibiotic, moxifloxacin, with or without linezolid. The trials showed that patients treated with Xenleta had similar clinical success rates to those treated with moxifloxacin with or without linezolid.

The most commonly reported adverse reactions in patients taking Xenleta were diarrhea, nausea, injection site reactions, elevated liver enzymes and vomiting. Xenleta may cause a change in ECG reading (prolonged QT interval). Patients whose QT interval is prolonged, those with certain irregular heart rhythms (arrhythmias), patients receiving treatment for some irregular heart rhythms (antiarrhythmic agents) and patients receiving other drugs prolonging the rhythm of arrhythmias. QT interval should avoid Xenleta. In addition, Xenleta should not be used in patients with known hypersensitivity to lecmaulin or any of the other members of the pleuromutilin antibiotic class, or to any of the Xenleta components. Based on the results obtained in fetal animals in animal studies, pregnant women and women who may become pregnant should be informed of the potential risks of Xenleta to the fetus. Women who may become pregnant should be advised of the use of effective contraception while taking Xenleta and for two days after the last dose.

Xenleta has received the FDA's Qualified Infectious Disease Product (QIDP) designation. The QIDP designation refers to antibacterial and antifungal drugs for the treatment of serious or life threatening infections under the FDA Safety and Innovation Act's Generating Antibiotic Incentives Now (GAIN). As part of the QIDP designation, Xenleta has obtained the Priority Review under which the FDA's goal is to respond to a request as soon as possible.

The FDA has approved Xenleta for Nabriva Therapeutics.

As a public health agency, the FDA faces a major global challenge, namely the fight against antimicrobial resistant infections. Among other FDA efforts to combat antimicrobial resistance, the focus is on facilitating the development of safe and effective new treatments to give patients more options to fight serious infections.

The FDA, an agency of the US Department of Health and Social Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.

###

Related information