Nabriva Therapeutics Announces Submission of Marketing Authorization Application for Lefamulin to Treat Community-Acquired Pneumonia in Adults by European Medicines Agency
Nabriva Therapeutics plc - Ordinary Shares (NBRV)
Last nabriva therapeutics plc - ordinary shares earnings: 3/12 04:01 pm
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Source: GlobeNewswire
DUBLIN, Ireland, May 08, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the Company’s marketing authorization application (MAA) for both the intravenous (IV) and oral formulations of 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 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 LEA
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