Drug Approvals

Shionogi antibiotic gets FDA ok with mortality warning

Nov 15, 2019

Japan's Shionogi announced the U.S. FDA has approved its new antibiotic, Fetroja, for the treatment of complicated urinary tract infections (cUTI).

The drug's label, however, will include a warning regarding the higher all-cause mortality rate observed in Fetroja-treated patients compared to those treated with other antibiotics.

According to the drugmaker, the new antibiotic will fill an important unmet medical need because of its unique method of penetrating the cell wall of Gram-negative bacteria and its ability to overcome many of the resistance mechanisms that bacteria employ against antibiotics.

The safety and effectiveness of Fetroja was demonstrated in a study of 448 patients with cUTIs. Of the patients who were administered Fetroja, 72.6% had resolution of symptoms and eradication of the bacteria approximately seven days after completing treatment, compared with 54.6% in patients who received an alternative antibiotic.

Read the FDA release