FDA grants Fetroja priority review for treatment of hospital-acquired bacterial pneumonia
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The FDA today granted priority review to cefiderocol for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia.
The agency accepted the supplemental new drug application for cefiderocol (Fetroja, Shionogi & Co.) and set a Prescription Drug User Fee Act date of Sept. 27.
“We are committed to working with the FDA in order to bring Fetroja to more patients fighting these challenging and life-threatening gram-negative infections as quickly as possible,” Akira Kato, PhD, president and CEO of Shionogi, said in a press release. “This submission represents our heritage in and commitment to developing antimicrobial therapies and filling unmet needs in the field of infectious disease.”
Results of the randomized phase 3 APEKS-NP study showed cefiderocol, a cephalosporin antibiotic, was noninferior to a high dose of extended-infusion meropenem in regard to all-cause mortality 14 days after administration of the study drug in patients with health care-associated, hospital-acquired and ventilator-associated bacterial pneumonia.
The drug was first approved in November 2019 for patients aged 18 years and older with limited or no other treatment options for complicated UTIs, including pyelonephritis, caused by gram-negative pathogens. It is the first approved antibiotic that works as a siderophore and has a novel mechanism for entering the outer cell membrane of gram-negative pathogens.
Disclosure: Kato is president and CEO of Shionogi Inc.
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