Nabriva Therapeutics Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application for Lefamulin
The EMA’s review of the application will follow the centralized marketing authorization procedure. If approved by the EMA, lefamulin will receive marketing authorization in all 28 member states of the
“We are grateful for the EMA’s quick validation of our MAA submission and look forward to working with the EMA during the MAA review process. We are committed to providing European patients with CAP the potential option of short course treatment with IV or oral lefamulin” said
Nabriva also has a New Drug Applications for lefamulin under review by the
Approximately 3 to 4 million cases of pneumonia occur annually in the EU (Gibson et al, 2013). Data from the Global Burden of Disease 2015 Study reported that lower respiratory tract infections, including pneumonia, were the third most common cause of death worldwide and the most common cause of infectious death globally, claiming 3 million lives annually (GBD, 2016; WHO, 2018). The impact on morbidity and mortality associated with community-acquired pneumonia is magnified in older patients, where data have shown that mortality is associated with advancing age (Welte et al, 2012; Cillóniz et al, 2013; Ochoa-Gondar et al, 2008). Approximately 90% of deaths due to pneumonia occur in people over 65 years old (EC, 2009a).
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
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Source: Nabriva Therapeutics US, Inc