XENLETA (lefamulin) Treatment of Community-Acquired Pneumonia (CAP): EU CHMP
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Last Update: 2020-06-24
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Source: Internet
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Author: User
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Community-acquired pneumonia (CAP) is the leading cause of morbidity and mortality worldwideThe clinical manifestations of CAP patients are different, which can be characterized by mild pneumonia characterized by fever and coughing sputum, as well as severe pneumonia characterized by respiratory distress and sepsisBecause of the wide clinical manifestations of CAP, the differential diagnosis of almost all respiratory diseases includes CAPPharmaceutical company Nabriva announced today that the European Medicines Agency (EMA) Human Medicines Commission (CHMP) has adopted a positive opinion recommending approval of XENLETA (lefamulin) treatment for adult patients with community-acquired pneumonia (CAP) who are not suitable for the use of CAP for initial treatment of antibiotics or treatment failuresCHMP is expected to make a regulatory decision in the second half of 2020Dr Jennifer Schranz, Chief Medical Officer of Nabriva, said: "XENLETA has a novel mechanism to provide a much-needed short course of treatment for adult CAP patientsWe look forward to the decision of the European Commission"two Phase III clinical trials have determined that XENLETA is no less than Mosissar in the treatment of adult CAPIn these trials, patients were well tolerated with lefamulin, and the most common adverse reactions were drug site reactions, diarrhea, nausea, vomiting, elevated liver enzymes, headaches, low blood potassium and insomnia
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