Instant Release:
19. August 2019

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

"This new drug provides another alternative for treating patients with community-acquired bacterial pneumonia, a serious disease," said Ed Cox, MD, MPH, director of the FDA's Office of Antimicrobial Products. “In order to deal with this serious illness, it is important for doctors and patients to have treatment alternatives. This approval reinforces our ongoing commitment to addressing infectious disease management 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 can vary in severity from mild to severe disease and can affect people of all ages. According to data from the Centers from Disease Control and Prevention, every year in the United States, about one million people are hospitalized with acquired pneumonia in the community, and 50,000 people die from the disease.

The safety and efficacy of Xenleta, taken either orally or intravenously, was evaluated in two clinical studies involving a total of 1

,289 patients with CABP. 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 the same rate of clinical success as those treated with moxifloxacin with or without linezolid.

The most common adverse reactions reported in patients taking Xenleta include diarrhea, nausea, injection site reactions, elevated liver enzymes and vomiting. Xenleta can potentially cause changes in ECG reading (extended QT interval). Patients with prolonged QT interval, patients with certain irregular heart rhythms (arrhythmias), patients receiving treatment for certain irregular heart rhythms (antiarrhythmic agents), and patients receiving other medications that prolong the QT interval should avoid Xenleta. In addition, Xenleta should not be used in patients with known hypersensitivity to lefamulin or other members of the pleuromutilin antibiotic class, or any of the components of Xenleta. Based on findings of birth defects in animal studies, pregnant women and women who may become pregnant should be informed of the potential risk of Xenleta to a fetus. Women who may become pregnant should be advised to use effective contraception during treatment with Xenleta and for two days after the final dose.

Xenleta received the FDA's Qualified Infectious Disease Product (QIDP) designation. The QIDP designation is given to antibacterial and antifungal drugs intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of the QIDP designation, Xenleta was given priority review as the FDA's goal is to take action against an application within an expedited timeframe.

FDA approved Xenleta to Nabriva Therapeutics.

An important global challenge the FDA faces as a public health agency addresses the threat of antimicrobial resistant infections. Among the FDA's other efforts to address antimicrobial resistance is the focus on facilitating the development of safe and effective new treatments to provide patients with more opportunities to fight serious infections.

The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for humans and medical devices. The agency is also responsible for the safety and security of the country's food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for the regulation of tobacco products.

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