US COPD Coalition

FDA Approves New Community-Acquired Pneumonia Treatment


The US Food & Drug Administration (FDA) has approved a new antibiotic to treat community-acquired bacterial pneumonia. The new drug, called Xenleta (lefamulin), is approved for adults and can be administered either orally or intravenously. “This new drug provides 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 FDA’s Office of Antimicrobial Products in a press release.

As the name suggests, community-acquired pneumonia occurs when someone develops pneumonia in the community (not in a hospital). The FDA’s press release notes that pneumonia “is a type of lung infection that can range in severity from mild to severe illness and can affect people of all ages.” The Centers for Disease Control and Prevention (CDC) reports that each year in the United States about one million people are hospitalized with community-acquired pneumonia and 50,000 people die from the disease. “For managing this serious disease, it is important for physicians and patients to have treatment options”, said Dr. Cox. “This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics.”

Read the full FDA press release here.