FDA approves new antimicrobial drugs to treat complex urinary tract infections

The U.S. Food and Drug Administration recently approved cefiderocol, an antimicrobial drug used to treat patients 18 years of age or older with complex urinary tract infections (cUTI), including kidney infections caused by susceptible Gloran-negative microorganisms, who have limited or no other treatment options.
"Today's approval provides an additional treatment option for patients with skin allergies who have limited or no other treatment options," said Dr. John Farley, acting director of the Infectious Diseases Office at the FDA Drug Assessment and Research Center. As a public health agency, a key global challenge facing the U.S. Food and Drug Administration is addressing the threat of antimicrobial infections such as skin. The approval marks another step forward in the U.S. Food and Drug Administration's overall effort to ensure patients have access to safe and effective antimicrobial treatments for infections. The
and effectiveness of fethroha was confirmed in a study of 448 patients with skin allergies. Of the patients treated with Fetroha, 72.6 per cent had symptoms alleviated about seven days after treatment and the bacteria had been eradicated, while 54.6 per cent of patients treated with alternative antibiotics. The clinical efficiency of the two treatment groups was similar.
Fetroga's label includes a warning that patients treated with the drug infested with Glorene-negative bacterial infections have a higher all-cause mortality rate than patients treated with other antibiotics in trials of critically ill patients with Gloga's negative bacterial infection. The cause of the increase in mortality has not yet been determined. Some deaths are due to worsening infections or complications, or potential complications. In patients treated for hospital-accessible/ventilator-related pneumonia (i.e., hospital-accessible pneumonia), blood flow infections or sepsis, the mortality rate was higher. The safety and effectiveness of Fetroja in treating such infections has not yet been determined.
The most common adverse reactions observed in patients treated with Fetroha include diarrhea, constipation, nausea, vomiting, elevated liver examination, rash, infusion site reaction, candica disease (yeast infection), cough, headache and hypokalemia (low potassium). Individuals known β a history of severe hypersensitive reactions to antimicrobial drugs such as steroids should not use amniotic globulin.
Fetroa was awarded the U.S. Food and Drug Administration's Qualified Infectious Disease Products (QIP) title.
QIP has been designated as an antimicrobial and antifmicrobial drug product for the treatment of serious or life-threatening infections under the title "Antibiotic Incentives For Immediate Generation" under the U.S. Food and Drug Administration's Safety and Innovation Act. As part of the qualified intermediary designation, Fetroha was given priority review, according to which the Food and Drug Administration aims to take action on applications within an accelerated time frame.
The Food and Drug Administration approved Sanogi Ltd.'s Fetroga drug. （cyy123.com）