A new antibiotic for complicated urinary tract infection (cUTI) has received approval from the U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee, according to a news release.
The investigational antibiotic cefiderocol is made by Shionogi & Co. of Japan. The FDA panel recommended — by a vote of 14-2 — approval of the antibiotic for the treatment of cUTI, including pyelonephritis, in patients with limited or no alternative treatment options.
As the release notes, the Advisory Committee provides the FDA with independent advice and recommendations. The FDA is not bound by the committee's guidance but takes its recommendation into consideration when reviewing investigational medicines.
Cefiderocol was designated as a qualified infectious disease product (QIDP) by the FDA. Under this designation, cefiderocol was previously granted "fast-track" status for FDA approval for its potential as a new antibiotic to treat serious or life-threatening conditions and address unmet medical needs.
While the FDA panel provided its recommendation, there were caveats, reports MedPage Today. These included suggestions for the inclusion of a boxed warning discussing potential mortality risk, with mention of a special risk among patients with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia, and the conducting of additional research and studies.
If cefiderocol receives FDA approval, it will be marketed under the brand name FETROJA.