FDA approves Shionogi's antibiotic Fetroja with spooky mortality warning label

Shionogi's newest antibiotic, Fetroja, has now earned the FDA's stamp of approval, a win for patients with certain antibiotic-resistant urinary tract infections and few treatment options.

But its official label warns of higher mortality rates with the new med compared with other antibiotics, showing just how badly today's doctors need treatments to tackle resistant infections. But the warning could also torpedo the drug's chances with physicians.

The FDA approved Fetroja (cefiderocol) on Friday to treat patients with complicated urinary tract infections, including kidney infections, caused by susceptible gram-negative microorganisms like E. coli. 

Shionogi said in a release Fetroja works by using a "unique method" to penetrate the bacteria's cell walls and attack microorganism strains growing increasingly resistant to antibiotics. 

The FDA's approval was based on phase 3 trial data showing Fetroja eradicated bacteria and resolved symptoms in 72.6% of patients after seven days. Only 54.6% of patients who received an alternative antibiotic hit the same primary endpoint. 

Fetroja will come with a serious warning label, however, after trial data showed a 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.

Shionogi said 24.8% of trial patients with hospital-acquired pneumonia, bloodstream infections or sepsis died after 28 days of treatment compared with 18.4% of patients with the same conditions treated with an alternative antibiotic. At the 49-day mark, 33.7% of Fetroja-treated patients with those conditions died compared with 20.4% treated with alternative drugs.

The FDA said the cause of that higher mortality rate is unknown. Some of the deaths were tied to worsening infection, complications and co-morbidities, 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.

RELATED: Mulpleta FDA nod in hand, Shionogi must distinguish it from competitor Dova's similar drug

Fetroja bears the FDA’s new Qualified Infectious Disease Product (QIDP) designation, a new pathway created by Congress and opened to antibiotics developed for serious or life-threatening infections. As part of that QIDP designation, Fetroja won priority review as well.