FDA Approves Lefamulin for Community-Acquired Bacterial Pneumonia


Both the oral and intravenous formulations of the novel pleuromutilin antibiotic were shown to be efficacious in 2 phase 3 studies.

The US Food and Drug Administration (FDA) has approved lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia (CABP) after results from 2 phase 3 studies showed the novel pleuromutilin antibiotic to be non-inferior to existing treatment options.

“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” said Ed Cox, MD, MPH, director of FDA’s Office of Antimicrobial Products in a statement issued by the FDA. “For managing this serious disease, it is important for physicians and patients to have treatment options. This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics.”

In total, the efficacy of lefamulin was evaluated in 1289 patients with CABP. In the LEAP 1 trial, IV to oral lefamulin was found to be non-inferior to IV to oral moxifloxacin with or without linezolid. In LEAP 2, lefamulin again successfully met the FDA primary endpoint of non-inferiority compared with moxifloxacin for early clinical response, which was evaluated in the intent-to-treat patient population 72 to 120 hours after treatment was initiated.

Lefamulin was shown to be well-tolerated with a favorable safety profile and can be dosed orally without regard to food, according to Jennifer Schranz, MD, chief medical officer with Nabriva Therapeutics.

“Lefamulin has benefits over other antibiotics for community acquired pneumonia. First, lefamulin is a new class of antibiotics. It’s a semi-synthetic derivative of this class called pleuromutilins, which is a derivative of a natural product—an oyster mushroom,” Schranz told Contagion® in an interview at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2019).

‘Why lefamulin is really important I think for physicians is it offers them the opportunity to treat patients as they would in real life,” she continued. “There's an IV-to-oral treatment option…we also have an oral-only phase 3 positive study, which showed a 5-day short course of lefamulin was non-inferior to a 7-day course of moxifloxacin.”

Pleuromutilin antibiotics are thought to work against pathogens that have previously thwarted other treatment regimens, which is especially important in light of a report from the US Centers for Disease Control and Prevention that in 40% of cases, pneumococcal bacteria are resistant to 1 or more antibiotics.

The approval of lefamulin also gives clinicians an alternative to fluoroquinolones, which have been plagued by safety warnings as of late, according to Thomas Lodise, PharmD, PhD, professor at Albany College of Pharmacy and Health Sciences.

“What we have is a new drug, an equivalent to the fluoroquinolones, that produces a similar response,” Lodise, an investigator on a post-hoc assessment of LEAP 1 & 2 presented at MAD-ID 2019, told Contagion®. “A few things that makes lefamulin attractive—much like a fluoroquinolone it has IV and oral bioequivalent formulations; you can take it with or without food, which is very important when we use drugs in the outpatient setting; and, overall appears to be safe and doesn't carry a lot of the adverse events that are attached to fluoroquinolones.”

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