www.fdanews.com/articles/198255-nabrivas-xenleta-approved-in-europe-for-community-acquired-pneumonia
Nabriva’s Xenleta Approved in Europe for Community-Acquired Pneumonia
July 29, 2020
The European Commission has approved Nabriva Therapeutics’ Xenleta for treatment of adults with community-acquired pneumonia when treatment with other antibacterial agents fails or is inappropriate.
The approval was based on results from two phase 3 trials which determined Xenleta to be non-inferior to the standard-of-care, moxifloxacin, for treating adults with the community-acquired infection.
The FDA approved Xenleta for this indication in August 2019.