Fetroja is designed to treat complications such as kidney infections caused by susceptible gram-negative microorganisms in patients over age 18 who have limited or no alternative treatments.
“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs,” said John Farley, MD, acting director of the FDA’s office of infectious diseases.
In a clinical trial, Fetroja resolved symptoms and eradicated bacteria in 76.2 percent of patients approximately seven days after treatment, compared to 54.6 percent of patients who received an alternative antibiotic.
The labeling for Fetroja includes a warning for an increased all-cause mortality rate observed in patients who were critically ill and had multidrug-resistant gram-negative bacterial infections and were treated with Fetroja, compared to other antibiotics. The reason for the increase in mortality rate hasn’t been established.
The most common side effects of Fetroja include diarrhea, constipation, nausea, vomiting and elevations in liver tests.
Fetroja is not designed for patients with a history of hypersensitivity to beta-lactam antibacterial drugs.
The FDA granted Fetroja qualified infectious disease product designation and priority review.
Read the full news release here.
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