Nabriva Therapeutics announced that the US FDA has approved the oral and intravenous (IV) formulations of lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia (CABP) in adults.
Lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic.
Both the IV and oral formulations of lefamulin were granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the FDA.
The FDA approval was based on a clinical development programme including two pivotal phase 3 trials (known as LEAP 1 and LEAP 2) that evaluated the safety and efficacy of IV and oral lefamulin compared to moxifloxacin in the treatment of adults with CABP.
LEAP 1 was designed to evaluate 5-to-7 days of IV/oral therapy of lefamulin versus 7-days of IV/oral moxifloxacin, with or without linezolid, with both treatment groups having the option to switch from IV to oral administration after 3-days.
LEAP 2 evaluated 5-days of oral lefamulin versus 7-days of oral moxifloxacin. LEAP 1 showed comparable efficacy with moxifloxacin, with or without linezolid, while LEAP 2 showed comparable efficacy with moxifloxacin, with two fewer days of therapy.
Lefamulin was generally well tolerated in both LEAP 1 and LEAP 2.
Nabriva expects lefamulin will be available through major US specialty distributors in mid-September 2019.