Key clinical point: Oral lefamulin was noninferior to oral moxifloxacin for inducing clinical response in patients with community-acquired bacterial pneumonia.
Major finding: The early clinical response rates at 96 hours for lefamulin and moxifloxacin were tied at 90.8%.
Study details: The data come from a phase 3, randomized trial of 738 adults from 99 sites in 19 countries.
Disclosures: The study was supported by Nabriva Therapeutics. Dr. Alexander and several coauthors are employees of Nabriva Therapeutics and own stock in the company.
Alexander E et al. JAMA. 2019 Sep 27. doi: 10.1001/jama.2019.15468.
“The development and approval of a new antibiotic is a rare occurrence and a reason to celebrate” given the scientific, regulatory, and economic challenges to antibiotic development, wrote Preeti N. Malani, MD, in an accompanying editorial. Lefamulin in both oral and intravenous forms was approved by the Food and Drug Administration in August 2019 for the treatment of community-acquired bacterial pneumonia, Dr. Malani said.
Lefamulin will likely be an expensive option. According to a manufacturer press release, lefamulin may cost $205/day for intravenous treatment and $275/day for oral treatment. “This is severalfold more than moxifloxacin or levofloxacin, which are the most commonly prescribed fluoroquinolones for CABP [community-acquired bacterial pneumonia],” said Dr. Malani. However, the addition of lefamulin to the array of antibiotics is important because of the persistent burden of bacterial pneumonia as an indication for antibiotic use, Dr. Malani emphasized.
Dr. Malani is affiliated with the University of Michigan, Ann Arbor, and serves as an associate editor of JAMA, but had no financial conflicts to disclose. These remarks were taken from an accompanying editorial (JAMA. 2019 Sep 27. doi:10.1001/jama.2019.16215).