Nabriva Therapeutics Announces Submission of Marketing Authorization Application for Lefamulin to Treat Community-Acquired Pneumonia in Adults by European Medicines Agency
The MAA filing is supported by two pivotal, Phase 3 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
“The MAA filing for lefamulin represents another major milestone for Nabriva as we continue to make significant progress toward our commitment of addressing the urgent and unmet medical need for novel anti-infective agents for patients with serious infections,” said Dr.
Based on Nabriva Therapeutics’ combined analysis of the
Lefamulin is a semi-synthetic pleuromutilin antibiotic with potential to be first-in-class for systemic administration in humans discovered and developed by the
Any statements in this press release about future expectations, plans and prospects for
Sam Brown Inc.
Source: Nabriva Therapeutics US, Inc