• Caroline Dillon, Anthony J Guarascio, and Jordan R Covvey.
• a Division of Pharmaceutical, Administrative and Social Sciences , Duquesne University School of Pharmacy , Pittsburgh , PA , USA.
• Expert Rev Anti Infect Ther. 2019 Jan 1; 17 (1): 5-15.

IntroductionCommunity-acquired bacterial pneumonia (CABP) represents a significant clinical and financial burden within infectious disease. In the advent of increasing resistance from bacteria such as Streptococcus pneumoniae to available antibiotic therapies, there is a need for new drugs with novel mechanisms to treat such infections. Areas covered: Lefamulin, the first semi-synthetic pleuromutilin for systemic administration, is nearing completion of Phase III studies for CABP; the manufacturer plans to file for a new drug application (NDA) in Q4 2018. This paper details available data on the pharmacokinetic, pharmacodynamic, in vitro and clinical data of the drug to date, derived from published literature, conference posters and data provided by the manufacturer. Expert commentary: Lefamulin offers a unique spectrum of activity as a potential monotherapy treatment agent for CABP and alternative to fluoroquinolone therapy. The drug displays potent activity against several pathogens common in both acute bacterial skin and skin structure infections (ABSSSIs) and CABP, and a lack of cross-resistance with other antibiotic classes for S. pneumoniae and Staphylococcus aureus. Lefamulin has met predefined noninferiority endpoints of clinical response for CABP compared to moxifloxacin ± linezolid in two Phase III trials (LEAP 1 and 2) and presents an alternative therapy for CABP.

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