Saturday , January 23 2021

FDA approves cefiderocol for complicated UTIs including pyelonephritis

Cefiderocol is a siderophor cephalosporin. Its mechanism of entry and stability is active against all classes of β-lactamases, allowing it to overcome the primary mechanisms of gram-negative bacterial resistance to βlactam antibiotics.

The US Food and Drug Administration has approved Fetroja (cefiderocol) for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) caused by susceptible gram-negative microorganisms, which have limited or no treatment options.

FDA has granted Fetroja approval to Shionogi & Co., Ltd.

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"Today's approval provides an additional treatment option for UTI patients who have limited or nonexistent alternative treatment options," said John Farley, MD, MPH, interim director of the Office of Infectious Diseases at the Center for Drug Research and Evaluation. FDA. “One of the key global challenges facing the FDA as a public health agency is addressing the threat of antimicrobial-resistant infections, such as cUTIs. This approval represents another step forward in the FDA's overall efforts to ensure that safe and effective antimicrobial drugs are available to patients to treat infections. "

The safety and efficacy of Fetroja have been demonstrated in a study of 448 patients with UTI. Of the patients receiving Fetroja, 72.6% had symptom resolution and bacterial eradication approximately seven days after the end of treatment, compared with 54.6% for patients receiving an alternative antibiotic. Clinical response rates were similar between the two treatment groups.

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Fetroja labeling includes a warning about the higher all-cause mortality rate observed in patients treated with Fetroja compared with those treated with other antibiotics in a study in critically ill patients with multidrug-resistant gram-negative bacterial infections. The cause of increased mortality has not been established. Some of the deaths resulted from worsening or complications of the infection or underlying comorbidities. The highest all-cause mortality rate was observed in patients treated by hospitalized patients.associated pneumonia (ie nosocomial pneumonia), bloodstream infections or sepsis. The safety and efficacy of Fetroja have not been established for the treatment of these types of infections.

The most common adverse reactions seen in patients treated with Fetroja included diarrhea, constipation, nausea, vomiting, elevated liver tests, rash, infusion site reactions, candidiasis (yeast infection), cough, headache and hypokalemia (low potassium). Fetroja should not be used in individuals with a known history of severe hypersensitivity to beta-lactam antibacterial medicinal products.

Fetroja received the FDA Qualified Infectious Disease Product (QIDP) designation. The QIDP designation is given to antibacterial and antifungal drugs intended to treat serious or life-threatening infections under the title of Generating Antibiotic Incentives Now (GAIN) of the FDA Safety and Innovation Act. As part of the QIDP designation, Fetroja has received the Priority Review, under which the FDA's goal is to act on an application within a timely manner.

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