By IDSE News Staff
The FDA approved a new indication for cefiderocol (Fetroja, Shionogi) for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible gram-negative microorganisms.
This expanded indication is based on the results of the phase 3 APEKS-NP study, which showed cefiderocol met the primary end point of noninferiority compared with high-dose, extended-infusion meropenem in all-cause mortality