For the first time in more than 15 years, the FDA has a systemic antibacterial drug with a novel mechanism of action to combat community-acquired bacterial pneumonia (CABP).

Lefamulin, which is marketed in oral and intravenous (IV) formulations as Xenleta, is indicated for adults with CABP. The drug is a semisynthetic that inhibits prokaryotic ribosomal protein synthesis through a unique mechanism that reduces its likelihood of developing resistance to bacteria or cross-resistance with the β-lactam, fluoroquinolone, glycopeptide, macrolide, and tetracycline antibiotic classes.

According to the Centers for Disease Control and Prevention, about people annually are hospitalized for pneumonia in the United States and some 50 000 people die of the disease. Although the causative agent can’t always be identified, are reported to cause more pneumonia cases than bacteria. However, a single bacterium—Streptococcus pneumoniae—is estimated to be involved in about 5% of all cases.