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Taiwan FDA approves Shionogi's FETROJA for treating complicated urinary tract infections

28 February 2024 | News

FETROJA is a siderophore cephalosporin antibiotic developed by Shionogi

Japan headquartered pharmaceutical company Shionogi & Co. has received approval from the Taiwan Food and Drug Administration (TFDA) for FETROJA (cefiderocol) in the treatment of complicated urinary tract infections, including pyelonephritis, and hospital-acquired pneumonia (including hospital-acquired bacterial pneumonia and ventilator-acquired associated bacterial pneumonia) caused by susceptible Gram-negative microorganisms. This approval applies to adult patients.

FETROJA is a siderophore cephalosporin antibiotic developed by Shionogi, and new drug application in Taiwan was filed on December 13, 2022. FETROJA exerts its antimicrobial activity by effectively penetrating the outer membrane of gram-negative bacteria, including multidrug-resistant bacteria, through the utilisation of the bacteria's iron transport system. FETROJA has been approved in Japan, Europe, and the United States and is currently being marketed in more than 10 countries and regions  and is expected to provide a new treatment option for Taiwanese patients suffering from infections caused by drug-resistant bacteria. Cefiderocol for injection is the first and only siderophore cephalosporin antibiotic for the treatment of serious Gram-negative infections. 

Shionogi has identified protecting people from the threat of infectious diseases as a material issue, and is working towards achieving comprehensive care for infectious diseases. As part of this commitment, the company is working with The Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI) to provide access to cefiderocol, with proper stewardship, in a wide range of low- and upper-middle-income countries.

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