FDA panel gives positive vote for Shionogi’s Cefiderocol in Urinary Tract Infections

pharmafile | October 18, 2019 | News story | Medical Communications  

The US FDA has recommended approval for cefiderocol, a novel antibiotic for complicated urinary tract infections, including pyelonephritis, in patients with limited or no other treatment options.

While members of the FDA’s Antimicrobial Drugs Advisory Committee were mostly impressed by the data submitted for the drug, voting 14-2 for recommendation, some raised concern about a mortality imbalance disfavouring cefiderocol in the CREDIBLE-CR study which compared the drug to current best available in therapy in patients with numerous carbapenem-resistant infections.

 Isao Teshigori, president and CEO at Shionogi, said: “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.

“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.”

David Smith, Professor of Medicine at the University of California San Diego stated that the drug needs “a circled and underlined warning” about a strong mortality signal. Other committee members indicated that a boxed warning discussing the mortality risk is certainly warranted.

The committee also went on to say that for this specific indication the sponsor has satisfied requirements however for more serious infections there needs to be more studies.

The Advisory Committee provides the FDA with independent advice and recommendations. It is not bound by the committee’s guidance but considers recommendations in reviewing investigational medicines.

Cefiderocol was designated as a Qualified Infectious Disease Product (QIDP) by the FDa and under this designation the drug was was granted Fast Tract status for its ability as a new antibiotic to treat serious or life-threatening conditions as well as addressing unmet medical needs.

Cefiderocol is a siderophore cephalosporin with a novel mechanism for pervading the outer cell membrane of Gram-negative pathogens as well as multidrug-resistant strains. It possesses a unique ability to overcome all three major mechanisms of carbapanem resistance.

Nik Kiran

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