Posted by Michael Wonder on 02 Jun 2020
FDA accepts Shionogi’s supplemental new drug application with priority review for Fetroja (cefiderocol) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
1 June 2020 - Shionogi today announced the U.S. FDA has accepted the company’s supplemental new drug application for Fetroja (cefiderocol) and granted priority review designation with a Prescription Drug User Fee Act date of 27 September 2020.
Shionogi submitted the application for Fetroja for the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible Gram-negative pathogens. HABP and VABP are also sometimes referred to as nosocomial pneumonia.
The application is based on results from the Phase III APEKS-NP study, which showed Fetroja met the primary endpoint of non-inferiority compared to high-dose extended-infusion meropenem in all-cause mortality 14 days after initiation of study drug in the treatment of patients with HABP, VABP and health care-associated bacterial pneumonia.
