Cefiderocol: new treatment option for Hospital-Acquired, ventilator associated pneumonia
Laboratory researcher, concept photo (stock image).
Credit: © tilialucida / stock.adobe.com
The U.S. Food and Drug Administration (FDA) has approved FETROJA® (cefiderocol) as a supplemental New Drug Application for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the various susceptible Gram-negative microorganisms.
Cefiderocol is a cephalosporin antibiotic with a novel mechanism of penetrating the tough outer membrane of gram-negative bacteria with and the ability to overcome resistance mechanisms used by gram-negative pathogens to evade antibiotics.
The antibiotic was initially approved for the treatment of complicated urinary tract infections. However, it has now become the first approved antibiotic that functions as a siderophore and has a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens including carbapenem-resistant strains.
"Antimicrobial resistance is a major global health concern, and there is a clear need for new treatments such as FETROJA to give clinicians more options to fight life-threatening infections caused by Gram-negative pathogens," said Akira Kato, Ph.D., president, and CEO at Shionogi Inc. "This milestone represents Shionogi's long-standing and unwavering commitment to constantly fight evolving infectious diseases in an era realizing significant unmet needs", he further adds.
The expanded indication is based on the results of phase 3 APEKS-NP trial, which showed that cefiderocol was non-inferior to meropenem for treating HABP/VABP patients; meaning 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 healthcare-associated bacterial pneumonia (HCABP).
"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 lead investigator Richard G. Wunderink, M.D., 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."
The APEKS-NP (Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae and Stenotrophomonas maltophilia in Nosocomial Pneumonia) was a multinational, multicenter, double-blind, randomized, trial aimed to study the effectiveness of FETROJA for the treatment of nosocomial pneumonia including HABP, VABP, and HCABP caused by Gram-negative pathogens.
Patients were randomized on a 1:1 basis to receive FETROJA administered by intravenous infusion of two grams over a three-hour period every eight hours or high-dose extended-infusion meropenem administered as two grams over a three-hour period every eight hours, for seven to 14 days in the hospital.
The researchers noted the following observations from the study-
a. FETROJA met the primary endpoint of non-inferiority to high dose meropenem, infused over three hours.
b. It also met key secondary endpoints of clinical outcomes at the test of cure (TOC) defined as seven days after treatment.
c. Clinical outcome at TOC: 64.8% FETROJA versus 66.7% meropenem high dose.
d. Day 28 ACM: 22.1% FETROJA versus 21.1% meropenem high dose.
The usage of the drug is primarily focused to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. While it is chiefly contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of FETROJA.
As a result, FETROJA met the primary endpoint to become the drug to be used in the treatment of patients with HABP, VABP and healthcare-associated bacterial pneumonia (HCABP).
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