EU approves Shionogi's new antibiotic Fetcroja for all KEY Gram-negative pathogens designated by THEA
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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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Japan's Shionogi's antibiotic Fetcroja (cefiderocol) has been granted permission by the European Union to treat adult patients with a limited selection of Gram-negative bacterial infectionsapproval was a major victory for Shionogi, with EU approval making Fetcroja the first antibiotic to be approved to cover all of the world's (WHO)-designated gram-negative pathogenswho released a list of bacteria in urgent need of new antibiotics in 2017 after observing an increase in antibiotic-resistant infectionsThe list highlights the urgency of Gram-negative bacteria, which are resistant to multiple antibiotics and have the 'inherent capacity' to find new ways to develop resistanceEU approval is based on data from Fetcroja's multi-country studies, which show that Fetcroja has significant in vitro activity against a wide range of oxycodone-negative pathogens and to certain bacteria containing resistant enzymesdata is also supported by three key clinical studies of antibiotics, including APEKS-cUTI and APEKS-NPAND and CR studiesIn these studies, Fetcroja showed efficacy in a variety of infections, including complex urinary tract infections (cUTI), hospital-acquired pneumonia (HAP), sepsis, and so onFectroja's new cell entry mechanism, like a Trojan horse, uses the bacteria's own iron-absorbing transport protein to effectively enter bacterial cells, enabling them to overcome the three main mechanisms by which Gram-negative bacteria are resistant to carbon penicillin
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