FDA Accepts Shionogi’s Supplemental New Drug Application with Priority Review for FETROJA® (cefiderocol) for the Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

Shionogi & Co., Ltd. (hereafter “Shionogi”) announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA^® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020. Shionogi submitted the sNDA for FETROJA for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative pathogens. HABP and VABP are also sometimes referred to as nosocomial pneumonia (NP).

“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,” said Akira Kato, Ph.D., president and CEO at Shionogi Inc. “This submission represents our heritage in and commitment to developing antimicrobial therapies and filling unmet needs in the field of infectious disease.”

The sNDA is based on results from the Phase III APEKS-NP study, which showed 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).