The EMA approved Nabriva Therapeutics’ (NASDAQ:NBRV) XENLETA for the treatment of community-acquired pneumonia.
The approval is based on efficacy data from two Phase 3 clinical trials, both of which established XENLETA to be non-inferior to the standard-of-care moxifloxacin in the treatment of community-acquired pneumonia in adults.
“The marketing authorization of XENLETA provides an important step forward for patients with community-acquired pneumonia, offering the first new antibiotic class approved by the EMA in nearly two decades,” Ted Schroeder, Nabriva’s CEO, said in a statement.
“Along with its short course, monotherapy regimen, and availability of both intravenous and oral formulations, XENLETA offers an important empiric treatment option for adult patients with community-acquired pneumonia, aligned with the core principles of antimicrobial stewardship,” he added.
The FDA approved XENLETA for the treatment of adult patients with community-acquired bacterial pneumonia in August 2019.