Antimicrobial resistance is increasing with each passing day. And to fight this dilemma, the U.S. Food and Drug Administration (FDA) has approved the use of an antibacterial drug, known as Fetroja (cefiderocol).
This drug can be used for treating patients aged 18 years or more, suffering from complicated urinary tract infections (cUTI). Some gram-negative microorganisms cause infections (kidney infections) that have limited treatment options. This drug is also helpful in such cases.
According to the acting director of the FDA’s Office of Infectious Diseases, John Farley, the FDA’s approval of Fetroja offers another option for managing UTIs in patients with limited or no alternative treatment options.
Handling the risk associated with infections showing antimicrobial resistance (UTIs) is a global challenge faced by the FDA as a public health organization. However, this approval corresponds to an advancement in the overall efforts made by the Food and Drug Administration to ensure the availability of effective and safe antimicrobial drugs for treating UTIs.
A study was conducted to study the efficiency and safety of this new antibacterial drug – Fetroja. It included 448 patients suffering from complicated urinary tract infections.
Nearly seven days after the treatment completion, the symptoms were resolved, and bacteria were eradicated in 72.6 percent of the patients receiving Fetroja. On the contrary, among those receiving an alternative antibiotic, the figure was 54.6 percent.
All-cause mortality rates were noted in a clinical trial that included critically ill-patients having multidrug-resistant Gram-negative bacterial infections. And the rates were much higher in patients treated with Fetroja compared to those receiving other antibiotics.
Fetroja should include this warning on its label. Up till now, the exact cause of this increased mortality rate hasn’t been founded. However, some deaths occurred due to the worsening of infection, complications related to it, or some underlying comorbidities.
Additionally, the higher all-cause mortality rate was also present in patients getting treatment for bloodstream infections, sepsis, or ventilator-associated/hospital-acquired pneumonia (such as nosocomial pneumonia.
FDA hasn’t established the efficacy and safety of Fetroja for the management of the above-mentioned types of infections.
The most common side effects witnessed in the patients receiving Fetroja for treatment were increased LFTs, constipation, diarrhea, vomiting, nausea, cough, headache, rash, and hypokalemia (low levels of potassium in the blood).
Moreover, candidiasis (infection caused by yeast) and infusion site reactions were also the most commonly observed adverse effects. Fetroja should be avoided in patients with a history of severe HSR (hypersensitivity reaction or anaphylaxis) to antibacterial drugs containing the beta-lactam ring.
FDA has designated Fetroja as QIDP – Qualified Infectious Disease Product and granted the approval of this new antimicrobial drug to Shionogi & Co., Ltd.
The designation of QIDP is given to antifungal and antibacterial drugs used for the purpose of treating life-threatening and serious infections present under the GAIN (Generating Antibiotic Incentives Now) title of the FDA Safety and Innovation Act.
Food and Drug Administration is a public health organization under the U.S. Department of Health and Human Services. As a part of its QIDP designation, Fetroja conferred the Priority review under which the objective of the FDA is to take action on a request within an accelerated time frame.