FDA Approves Cefiderocol for Hospital-acquired Bacterial Pneumonia

Shionogi announced today that the FDA has approved a supplemental New Drug Application for cefiderocol for the treatment with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms in patients 18 years of age or older.

“Antimicrobial resistance is a major global health concern, and there is a clear need for new treatments such as FETROJA (cefiderocol) to give clinicians more options to fight life-threatening infections caused by Gram-negative pathogens,” said Akira Kato, PhD, 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.”

Cefiderocol is currently approved for patients 18 years of age or older for the treatment of complicated urinary tract infections, including pyelonephritis, caused by Gram-negative pathogens. It is 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. This expanded indication is based on the results of the phase 3 APEKS-NP study, which showed cefiderocol 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).

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