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A robust antibiotic pipeline is essential for patient care and public health. Yet compared with other classes of drugs, the development of antibiotics presents unique scientific, regulatory, and economic challenges. Most notably, antibiotics provide less financial reward for pharmaceutical companies because these medications are used for a short duration and newer agents are often restricted for use only in the setting of antimicrobial resistance. In fact, most large pharmaceutical companies have reduced or stopped antibiotic research altogether, leaving the critical task of discovering new antibiotics to small companies with limited budgets and research capacity. For these and other reasons, the development and approval of a new antibiotic is a rare occurrence and a reason to celebrate.
In this issue of JAMA, Alexander et al1 report the findings of the Lefamulin Evaluation Against Pneumonia 2 (LEAP 2) trial, a phase 3, randomized, noninferiority trial that compared 5-day oral lefamulin with 7-day oral moxifloxacin in the management of community-acquired bacterial pneumonia (CABP). In this trial of 738 patients, the primary outcome of early clinical response at 96 hours (within a 24-hour window) after the first dose of study drug was 90.8% in the lefamulin group and 90.8% in the moxifloxacin group, a difference that met the noninferiority margin of 10%. Patients in the lefamulin group reported a higher incidence of gastrointestinal-related treatment-emergent adverse effects (17.9% vs 7.6% in the moxifloxacin group), primarily diarrhea.
Lefamulin (both intravenous and oral formulation) was approved in August 2019 by the US Food and Drug Administration (FDA) to treat CABP. This approval was based on data in the current LEAP 2 study as well as the previously published LEAP 1 study.2 Although lefamulin will offer another oral option to treat CABP, the spectrum of activity is similar to fluoroquinolones. In recent years, more attention has been given to uncommon but serious adverse effects associated with fluoroquinolone use including Q-T prolongation, hypoglycemia, and tendinitis and tendon rupture.
Cost will likely be a barrier to lefamulin use. A press release from the manufacturer stated that the wholesale acquisition cost of lefamulin will be $205 per day for intravenous treatment and $275 per day for oral treatment.3 This is several-fold more than moxifloxacin or levofloxacin, which are the most commonly prescribed fluoroquinolones for CABP. Tolerability (especially diarrhea and vomiting) may be another issue, and deserves close postmarketing monitoring. Despite these concerns, lefamulin is an important addition to the current antibiotic armamentarium, especially because bacterial pneumonia remains one of the most common indications for antibiotic use.4,5
Published Online: September 27, 2019. doi:10.1001/jama.2019.16215
Corresponding Author: Preeti N. Malani, MD, MSJ, 4135F University Hospital South, 1500 East Medical Center Dr, Ann Arbor, MI 48109 (firstname.lastname@example.org).
Conflict of Interest Disclosures: None reported.
Malani PN. Lefamulin—A New Antibiotic for Community-Acquired Pneumonia. JAMA. 2019;322(17):1671–1672. doi:https://doi.org/10.1001/jama.2019.16215
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