Skip to NavigationSkip to content

Shionogi gains US approval in complicated urinary tract infections with Fetroja

Published on 15/11/19 at 12:57pm

Shionogi’s antibacterial therapy Fetroja (cefiderocol) has secured approval in the US for the treatment of complicated urinary tract infections (cUTI), it has emerged.

The approval relates specifically to adult patients with cUTI’s including kidney infections caused by susceptible Gram-negative microorganisms who have limited or no alternative treatment options. The ruling was made under the Qualified Infectious Disease Product (QIDP) designation.

Supporting the approval was data that showed that 72.6% of Fetroja patients saw a complete eradication of bacteria and resolution of symptoms within seven days of finishing treatment, compared to 54.6% with an alternative antibiotic therapy, with comparable response rates across both groups.  

However, despite the approval the FDA has required that the drug’s label feature a warning on the higher all-cause mortality rate associated with its use in critically ill patients with multidrug-resistant Gram-negative bacterial infections compared to other antibiotics. Observed in cases of hospital-acquired/ventilator-associated pneumonia, bloodstream infections, or sepsis, it is not yet understood what causes this rise in mortality rates.

“Today’s approval provides an additional treatment option for patients with cUTIs who have limited or no alternative treatment options,” remarked Dr John Farley, acting Director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections.”

Matt Fellows

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches