First new oral and IV antibiotic with novel mechanism of action approved in nearly two decades


Nabriva Therapeutics (Dublin, Ireland) have announced that the US FDA have approved their new drug applications for the oral and intravenous (IV) formulations of Xenleta™ (lefamulin) to treat adult patients with community-acquired bacterial pneumonia (CABP). This is the first new antibiotic with a novel mechanism of action approved by the FDA in nearly two decades.

The FDA approval was based on a clinical development program supported by a robust data package, including two pivotal Phase II clinical trials – LEAP 1 and LEAP 2 – evaluating the safety and efficacy of Xenleta compared with moxifloxacin in adult CABP cases. Both trials demonstrated that oral and IV Xenleta was comparable with moxifloxacin in terms of efficacy, and that the new antibiotic was generally well tolerated.

Ted Schroeder, Chief Executive Efficer of Nabriva Therapeutics, commented: “Today’s approval of Xenleta is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP.”

“Xenleta has a mechanism of action that is different than other approved antibiotics, resulting in a low propensity for the development of resistance, as well as a lack of cross-resistance with the beta-lactam, fluoroquinolone, glycopeptide, macrolide and tetracycline antibiotic classes. Xenleta has a targeted in vitro spectrum of activity against the most common causative Gram-positive, Gram-negative and atypical pathogens associated with CABP, which aligns with the principles of antimicrobial stewardship.”

Nabriva expects the new antibiotic Xenleta will be available through major US specialty distributors in mid-September 2019. Xenleta  will have a wholesale acquisition price of US $205 per IV patient treatment day and US $275 per oral patient treatment day.

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When was the last new class of antibiotics introduced?

The last new class of antibiotics introduced was the lipopeptides, introduced in 2003. However, the last new class of antibiotic approved for community-acquired pneumonia was oxazolidinones in the year 2000. Prior to this there was a huge gap, with the previous approval for trimethoprim occurring in 1968.

What is community-acquired bacterial pneumonia?

Community-acquired pneumonia is defined as pneumonia that is acquired outside a hospital or healthcare setting, or that presents within 48 hours of admission in patients without any previous encounter with healthcare.


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