An FDA committee voted to recommend the approval of cefiderocol for the treatment complicated UTIs, or cUTIs, in patients with few or no alternative treatment options.
The Antimicrobial Drugs Advisory Committee voted 14-2 in favor of the recommendation.
“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,” Shionogi President and CEO Isao Teshirogi, PhD, said in a news release.
Cefiderocol, an investigative antibiotic with a novel mechanism for penetrating gram-negative pathogens, including multidrug-resistant strains, can overcome all three major mechanisms of carbapenem resistance, according to the Shionogi release. It was previously designated as a Qualified Infectious Disease Product by the FDA and was granted fast-track status for its potential as a new antibiotic to treat serious or life-threatening conditions.
According to the news release, the assigned action date is Nov. 14.
The FDA committee met Oct. 16 to review and evaluate data on the safety and effectiveness of cefiderocol. Members discussed data from three studies, including one, the CREDIBLE-CR study, that showed a higher all-cause mortality rate in patients treated with cefiderocol compared with the best available therapy.
“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,” Teshirogi said. – by Caitlyn Stulpin
Shionogi. Antimicrobial Drugs Advisory Committee cefiderocol briefing document. file:///C:/Users/ggallagher/Downloads/AMDAC-20191016-BackgrounderFShionogi.pdf. Accessed October 17, 2019.
Disclosures: Teshirogi is an employee of Shionogi.