Nabriva Therapeutics Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application for Lefamulin
Nabriva Therapeutics plc, a clinical-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, today announced that the European Medicines Agency (EMA) has determined that the Company’s Marketing Authorization Application (MAA) for 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, is valid. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process and an opinion of the EMA Committee for Medicinal Products for Human Use (CHMP) is anticipated in the next 12 to 15 months.
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