FDA accepts Fetroja sNDA for priority review

The US Food and Drug Administration has accepted the 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.

Japanese drug major Shionogi (TYO: 4507), whose shares rose 2.7% to 6,190 yen following the announcement yesterday, 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, president and chief executive at Shionogi Inc, adding: “This submission represents our heritage in and commitment to developing antimicrobial therapies and filling unmet needs in the field of infectious disease.”