FDA approves cefiderocol for hospital-acquired, ventilator-associated bacterial pneumonia
The FDA has approved Fetroja for patients aged 18 years or older with hospital-acquired and ventilator-associated bacterial pneumonia, Shionogi announced.
The approval is based on results from the phase 3 APEKS-NP trial, which showed that Fetroja (cefiderocol) was noninferior to high-dose extended-infusion meropenem in regard to all-cause mortality 14 days following initiation.
“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,” APEKS-NP principal investigator Richard G. Wunderink, MD, professor of pulmonary and critical care at the Northwestern University Feinberg School of Medicine, said in a press release. “The results from the APEKS-NP study show that cefiderocol is a much-needed additional option for the treatment of patients with [hospital-acquired bacterial pneumonia] and [ventilator-associated bacterial pneumonia] due to multidrug-resistant gram-negative bacteria.”
The FDA accepted a supplemental new drug application for the indications and granted cefiderocol priority review in early June.
Ventilator-associated and nosocomial bacterial pneumonia are often caused by gram-negative bacteria such as Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Pseudomonas aeruginosa, Klebsiella pneumoniae and Serratia marcescens.
“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,” Shionogi President and CEO Akira Kato, PhD, said in the release.