A panel of the FDA’s Antimicrobial Advisory Committee voted 14-2 to approve cefiderocol, a new anti-bacterial drug for complicated urinary tract infections (c-UTIs) and pyelonephritis in patients who have no or limited drug options.
While most panel members were impressed by the clinical data of the drug, some had concerns about its “mortality imbalance.”
The committee discussed how to interpret cefiderocol’s mortality, provide recommendations for a warning label, and the need for additional studies.
Dr. Lindsay Baden, who is affiliated with Brigham and Women’s Hospital in Boston, “[Do we] find the mortality imbalance in CREDIBLE … credible enough?”
Although the panel members voted in favor of the drug’s approval, they did not completely ignore its mortality imbalance. They explained that the data they received was uneven. The members also were unsure about the CREDIBLE data.
When asked whether the increased mortality was a substantive finding, the committee said, “They did not think the committee could discuss the risk/benefit [of cefiderocol] for UTI alone without having this information [about increased mortality] at hand.”
Most members agreed that the drug needs a strong warning label, given the enormous burden of multidrug-resistant infection and the certainty that the drug would be used off-label for other infections. The advisory committee members said a boxed warning mentioning the potential mortality risk should be warranted.
Dr. Peter Weina and Susan May voted “no” and stated that additional trials are required to ease their concerns.
Roblena Walker, Consumer Representative, who voted “yes,” said, “I was a little torn here, but I thought about my 90-year-old grandmother who suffered from a UTI when she was 88 and I listened to the public comments [and] the physicians [who said] patients … could’ve benefited from this.” Medical Director of Executive Medicine in Washington, DC, Arthur Lyons, summarized the thinking of many of the members. He said, “For the specific indication addressed here, the sponsor has satisfied the requirements. But for other more serious infections … there need to be more studies.”
