FDA approves Nabriva's innovative antibiotic Xenleta (lefamulin) for use in treatment of CABP
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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Community Acquired Bacterial Pneumonia (CABP), a bacterial pneumonia that is developed outside the hospital environment, is one of the most common infectious diseases that threatenshealth(http://populationPneumonia is the leading cause of death from infectious diseases worldwide, with severity ranging from mild to severe and can affect people of all agesToday, nabriva(http:// announcedthat it hadfda
(http://approved the company's innovative antibiotic, Xenleta ,lefamulin, to treat adult patients with CABPAbout lefamulin
Nabriva developed lefamulin is an innovative pheromone class antibiotic that can be administered intravenously or or orallyBy combining with the peptide-based transfer enzyme center (PTC) of bacterial ribosomes, the proteinsynthetic(http:// of bacteria can be inhibited, thus achieving the effect of inhibiting bacterial growth Lefamulin is effective in targeting pathogens that cause respiratory diseases ( including multiple resistant strains) while bacteria are less resistant to it and do not develop resistance to other types of antibiotics as a result Lefamulin has been awarded priority review by the FDA, fast-track eligibility and qualified infectious disease product (http:// (QIDP) This approval is based on the positive results of two critical Phase 3 clinical trials
(http:// LEAP 1 and LEAP 2 clinical trials assessed the safety and efficacy of treatment of adult CABP in both intravenous and oral lefamulin compared to moxifloxaxin, with a total of 1,289 patients participating The results showed that lefamulin's efficacy was non-inferior than moxisha stars
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