U.S. FDA Advisory Committee recommends approval of cefiderocol for treatment of complicated urinary tract infections

October 16, 2019 Off By BusinessWire

Shinogoi might have cefiderocol approved by the US FDA, as the Advisory Committee reccomends it for treatment of complicated urinary tract infections, which will be marketed under the brand name Fetroja.

OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee voted to recommend approval of the investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options. The Advisory Committee voted 14 to 2 that Shionogi provided substantial evidence about the efficacy and sufficient evidence of the safety of cefiderocol as part of its New Drug Application (NDA).

“We are pleased with the positive recommendation for the approval of cefiderocol for the treatment of cUTI. We appreciate the conscientious review of our data by the committee members and will continue to work closely with the FDA as it completes the review of our submission,” said Isao Teshirogi, Ph.D., president and CEO. “Patients with cUTIs caused by Gram-negative pathogens continue to face a serious challenge with high morbidity and mortality rates. If approved, we believe cefiderocol could help address a significant unmet need in an area with limited treatment options to fight these life-threatening infections.”

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 granted Fast Track status for its potential as a new antibiotic to treat serious or life-threatening conditions and to address unmet medical needs. The assigned action date is November 14, 2019 under the Prescription Drug User-Fee Act (PDUFA).