Shionogi Co., Ltd, a prominent Japanese pharmaceutical company, has announced the filing of a New Drug Application (NDA) in China for its innovative next-generation siderophore cephalosporin antibiotic, cefiderocol. The drug, marketed as Fetcroja or Fetroja in 10 different markets including Europe, Japan, and the United States, is now under consideration for approval in China. Shionogi is seeking regulatory approval for cefiderocol to treat infections caused by gram-negative bacteria, including those that are multidrug-resistant. The application is supported by Phase III clinical trial data from China, which involved 150 patients with complicated urinary tract infections. The study demonstrated that cefiderocol showed superior efficacy against the comparator drug, imipenem/cilastatin, without raising any new safety concerns.
Shionogi has been at the forefront of combating antimicrobial resistance (AMR), a growing global health threat where bacteria develop resistance to antibiotics, potentially rendering them ineffective. The issue of AMR is particularly pertinent in China, where it was directly linked to 145,500 deaths in 2019, and was associated with an additional 602,600 deaths, as highlighted in the company’s press release.- Flcube.com
