The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Fetroja® (cefiderocol; Shionogi) for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative microorganisms.
The approval is supported by data from the double-blind, noninferiority phase 3 APEKS-NP trial that compared the safety and efficacy of Fetroja to meropenem in hospitalized adults with HABP, VABP, or healthcare-associated bacterial pneumonia. Patients were randomized to receive Fetroja 2g intravenously (IV) every 8 hours (n=145) or meropenem 2g IV every 8 hours (n=147) for a period of 7 to 14 days, in addition to linezolid (to cover methicillin-resistant Staphylococcus aureus and Gram-positive bacteria).
Results showed that Fetroja met the primary end point of noninferiority for all-cause mortality at day 14 compared with meropenem (12.4% [n=18/145] vs 12.2% [n=18/147], respectively; difference 0.2; 95% CI: -7.2, 7.7). Additionally, Fetroja demonstrated to be noninferior to meropenem for key secondary end points including clinical outcome at test of cure (64.8% vs 66.7%, respectively), defined as 7 days after treatment, and all-cause mortality at day 28 (22.1% vs 21.1%, respectively).
With regard to safety, the incidence of treatment-emergent adverse events was found to be similar between Fetroja (87.8% [n=130/148]) and meropenem (86% [n=129/150]).
“Nosocomial pneumonia is one of the most common hospital-acquired infections and a rising number are caused by difficult-to-treat, multidrug-resistant pathogens, which can be a deadly threat for patients,” said APEKS-NP principal investigator Richard G. Wunderink, MD, Northwestern University Feinberg School of Medicine. “The results from the APEKS-NP study show that cefiderocol is a much-needed additional option for the treatment of patients with HABP and VABP due to multidrug-resistant Gram-negative bacteria.”
Fetroja, a cephalosporin antibacterial, is already indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible Gram-negative microorganisms, in patients aged 18 years and older.
The product is available as lyophilized powder for reconstitution in single-dose vials containing 1g of cefiderocol.
For more information visit shionogi.com.
- Shionogi announces FDA approval of Fetroja® (cefiderocol) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. https://www.shionogi.com/us/en/news/2020/9/shionogi-announces-fda-approval-of-fetroja-cefiderocol-for-the-treatment-of-hospital-acquired-bacterial-pneumonia-and-ventilator-associated-bacterial-pneumonia.html. Accessed September 28, 2020.
- Fetroja [package insert]. Florham Park, NJ: Shionogi Inc.; 2020.