FDA clears Nabriva's Xenleta for community-acquired bacterial pneumonia

Nabriva Therapeutics on Monday announced that the FDA approved Xenleta (lefamulin), in both oral and intravenous formulations, for use in adults with community-acquired bacterial pneumonia (CABP). The company indicated that the drug, which it described as a "first-in-class semi-synthetic pleuromutilin antibiotic," will be launched in the US in mid-September at a list price of $205 per day for the injectable formulation, and $275 per day for the oral version. Shares in Nabriva gained as much as 23% on the news. 

CEO Ted Schroeder said the approval "is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed [intravenous] and oral empiric monotherapy treatment option for adults with CABP." He noted that Xenleta's mechanism of action "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."  

Approval of the drug was backed by a clinical development programme that included the Phase III LEAP 1 and LEAP 2 studies comparing Xenleta with moxifloxacin for the treatment of CABP in adults. In the LEAP 1 study of 551 adults with moderate-to-severe CABP, Xenleta was found to be non-inferior to moxifloxacin, with or without adjunctive linezolid, regarding the primary endpoint of early clinical response in the intent-to-treat patient population. Meanwhile, data from the LEAP 2 trial showed that Xenleta had comparable efficacy with moxifloxacin, but with two fewer days of therapy. However, while Xemleta was generally well-tolerated in both studies, concerns were raised over gastrointestinal side effects associated with the drug in LEAP 2. 

In May, the FDA rejected Nabriva's Contepo (fosfomycin) for the treatment of complicated urinary tract infections due to production issues at a contract manufacturer. The drugmaker recently announced that it aimed to resubmit the treatment for approval in the fourth quarter. Wedbush analyst Robert Driscoll has said Xenleta "is a bigger opportunity than Contepo, but we still don't think Contepo is dead…there's just a little delay going on there with the FDA." The analyst suggested that Xenleta may struggle at first as it penetrates the market, and he forecasts peak sales of $267 million by the end of 2025 for the antibiotic. 

The FDA previously granted Xenleta a Qualified Infectious Disease Product, as well as fast-tract status for the treatment of CABP and acute bacterial skin and skin structure infections. Meanwhile, Xenleta remains under review in Europe for the treatment of community-acquired pneumonia in adults.

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