Ireland-headquartered Nabriva Therapeutics received approval from the US Food and Drug Administration (FDA) for Xenleta (lefamulin), a systemic pleuromutilin antibiotic for bacterial pneumonia acquired outside of hospital (community-acquired).
Ted Schroeder, Nabriva’s CEO, said in a statement that the approval is part of the fight against the “growing threat of antimicrobial resistance.”
Schroeder said that the product has a different mechanism of action than other approved antibiotics, resulting in low likelihood for resistance development, as well as a decreased risk of cross-resistance with other antibiotic classes including beta-lactam, fluoroquinolone, glycopeptide, macrolide, and tetracycline.
“Xenleta has a targeted in vitro spectrum of activity against the most common causative Gram-positive, Gram-negative and atypical pathogens associated with community-acquired bacterial pneumonia, which aligns with the principles of antimicrobial stewardship,” Schroeder added.
Ed Cox, director of FDA's office of antimicrobial products, commented that the approval provides another treatment option for patients and physicians, which is an important factor for managing the disease.
The FDA had granted the drug qualified infectious disease product (QIDP) designation and priority review. According to the agency, the focus on facilitating the development of such treatments is among its efforts to address antimicrobial resistance.
In clinical trials, patients treated with Xenleta had similar rates of clinical success as those treated with moxifloxacin, another antibiotic.
The product will be marketed in oral and intravenous formulations and is expected to be available on the US market by September 2019. The drug will cost $205 (€184) for intravenous and $275 (€247) for oral administration per treatment day.
About one million people are hospitalized with community-acquired pneumonia each year in the US and 50,000 people die from the disease, according to the US Centers for Disease Control and Prevention.