BC 3781 file with EU for community-acquired pneumonia

Nabriva Therapeutics announced that the Company’s marketing authorization application (MAA) for both the intravenous (IV) and oral formulations of BC 3781 (lefamulin), a potentially first-in-class, semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired pneumonia (CAP) in adults 18 years of age and older, has been submitted to the European Medicines Agency (EMA). If approved, Nabriva intends to work with a commercial partner to make lefamulin available to patients in the EU.

The MAA filing is supported by two pivotal, Phase III clinical 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 CAP. LEAP 1 was designed with the option to switch from IV to oral administration, while LEAP 2 was designed as a short course, 5-day, oral only treatment with lefamulin. In both LEAP 1 and LEAP 2, lefamulin was demonstrated to be non-inferior to moxifloxacin, and met both the EMA and U.S. Food and Drug Administration (FDA) primary and secondary efficacy endpoints for the treatment of CAP. Lefamulin was also shown to be generally well-tolerated when administered either orally or intravenously.

Comment: Nabriva Therapeutics believes lefamulin represents a potentially important new treatment option for the approximately five to six million adults in the United States diagnosed with CABP each year.