U.S. FDA Approves Lefamulin for Community-Acquired Bacterial Pneumonia

On August 19, the U.S. FDA announced its approval of lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia (CABP). The drug is designed to be given either intravenously (150 mg every 12 hours for 5–7 days) or orally (600 mg every 12 hours for 5 days). Lefamulin is a semisynthetic pleuromutilin protein synthesis inhibitor antibiotic that binds to the peptidyl transferase center of the 50S subunit of the bacterial ribosome, preventing protein synthesis (Pharmacotherapy 2018; 38:935).

The approval was based on two global phase 3 clinical trials, LEAP 1 and 2. In LEAP 1, intravenous lefamulin demonstrated noninferiority to moxifloxacin (with or without linezolid) for the primary endpoint of early clinical response (ECR)…