Caveats

However, it should be clearly recognized these trials and publications are produced in their entirety by the sponsor, Nabriva Therapeutics. The vast majority of authors are either employees of, consultants for, or members of the board of directors for Nabriva. There are clear professional and corporate financial interests tied to conducting the ideal trial leading to approval and to presenting these data in the best possible light. These biases do not imply misconduct nor misleading factual presentation, but they may limit generalizability of the effectiveness and safety profile to real-world use.

Regardless, lefamulin is likely to become an important antibiotic option in human medicine. Its long, effective use in veterinary medicine supports the findings observed in these trials. As with any new antibiotic, stewardship will be critical. While the trade magazine advertisements for Xenleta are likely to surge, our prescribing should not follow suit. The narrow eligibility of these trials, the drug’s use in low-acuity patients, the relative paucity of safety information, and, of course, the drug’s increased cost compared with current generic options all reduce its appropriateness. Antibiotics such as this, with unique mechanisms of action, should be held in reserve for cases in which established resistance limits alternative options. These data portend a welcome advance in our treatment options for otherwise challenging infections but are best restricted to such narrow indications.

The opinions expressed herein are solely those of Dr. Radecki and do not necessarily reflect those of his employer or academic affiliates.

References

1. Veve MP, Wagner JL. Lefamulin: review of a promising novel pleuromutilin antibiotic. Pharmacotherapy. 2018;38(9):935-946.
2. File TM Jr, Goldberg L, Das A, et al. Efficacy and safety of IV-to-oral lefamulin, a pleuromutilin antibiotic, for treatment of community-acquired bacterial pneumonia: the phase 3 LEAP 1 trial [published online ahead of print Feb. 4, 2019]. Clin Infect Dis.
3. Alexander E, Goldberg L, Das A, et al. LB6. Oral lefamulin is safe and effective in the treatment of adults with community-acquired bacterial pneumonia (CABP): results of lefamulin evaluation against pneumonia (LEAP 2) study. Open Forum Infect Dis. 2018;5(suppl 1):S761.
4. Alexander E, Goldberg L, Das A, et al. Oral lefamulin demonstrates favorable safety and tolerability in adults with community-acquired bacterial pneumonia in the phase III lefamulin evaluation against pneumonia (LEAP 2) study. In: Proceedings from the 29th European Society of Clinical Microbiology and Infectious Diseases; April 13–16, 2019; Amsterdam, The Netherlands. Abstract O1068.