34. Fetroja

Antibiotic-resistant bacteria

Active ingredient: cefiderocol
Disease: urinary tract infections
Peak sales estimate: n/a
Approved: Nov. 15, 2019
Company: Shionogi

The scoop: Federal regulators are so desperate for novel solutions to antibiotic-resistant bacteria that they’re willing to give their blessing to drugs with spooky safety profiles. Take Shionogi’s Fetroja (cefiderocol), which received FDA approval in November to treat certain antibiotic-resistant urinary tract infections. Fetroja works by using a "unique method" to penetrate the bacteria's cell walls and attack microorganism strains growing increasingly resistant to antibiotics, Shionogi said, but the drug will come with a serious warning label. Phase 3 trial data showed a higher rate of death from any cause in patients treated with the drug compared to those treated with other antibiotics. That mortality rate showed up in a trial in critically ill patients with a variety of multidrug-resistant, Gram-negative bacterial infections. The FDA said the cause of that higher mortality rate is unknown. Some of the deaths were tied to worsening infection, complications and comorbidities, the agency said in a release. Shionogi said Fetroja should only be used for patients with limited treatment options and cautioned physicians to "closely monitor" their patients' clinical responses. –– Kyle Blankenship

34. Fetroja

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