Australia Accepts New Drug Application for Cefiderocol

OSAKA, Japan, December 03, 2024 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereinafter, "Shionogi") is pleased to announce that their new drug application for cefiderocol, an innovative treatment for gram-negative bacterial infections, has been accepted by the Therapeutic Goods Administration (TGA) in Australia.

Cefiderocol has undergone three extensive global trials: a Phase 2 trial for patients with complicated urinary tract infections (APEKS-cUTI), a Phase 3 trial for patients with carbapenem-resistant gram-negative bacterial infections (CREDIBLE-CR), and another Phase 3 trial for patients with nosocomial pneumonia (APEKS-NP). The acceptance of this application is based on the solid results obtained from these trials.

Cefiderocol is a highly effective antibiotic that can penetrate the outer membrane of gram-negative bacteria, including strains resistant to multiple drugs. It is currently available in 25 countries and regions around the globe, including Japan, Europe, the United States, and Taiwan. It is marketed under different trade names: Fetroja® in the United States and Taiwan, Fetcroja® in Europe, and Fetroja® in Japan. Additionally, numerous real-world studies have been published, highlighting its efficacy in treating severe infections. Cefiderocol is also included in the World Health Organization's Essential Medicines List, which comprises medicines considered to be most effective, safe, and cost-efficient for priority health conditions.

Shionogi has made a commitment to addressing the threat of infectious diseases as a significant issue and is working towards comprehensive care for such illnesses. By delivering crucial treatments for infectious diseases to patients worldwide swiftly, Shionogi aims to contribute to managing global challenges, including COVID-19 and antimicrobial resistance (AMR).

Cefiderocol is the first and only siderophore cephalosporin antibiotic developed for serious gram-negative infections. It employs a unique method to penetrate the outer cell membrane of gram-negative bacteria by functioning as a siderophore. This allows it to bind to ferric iron and be actively transported into bacterial cells through the outer membrane via bacterial iron transporters. These transporters help incorporate this essential nutrient for the bacteria. This process enables cefiderocol to achieve high concentrations in the periplasmic space, where it binds to penicillin-binding proteins, inhibiting cell wall synthesis in bacterial cells. Preparations are being made through collaborations with the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI) to enhance access to this new antibacterial treatment in many low- and middle-income countries, as well as high- and middle-income regions.

Antimicrobial resistance (AMR) poses a global public health threat, with bacteria increasingly becoming resistant to antibiotics. This issue needs urgent attention and cooperation on a global scale. In 2019, it was estimated that 1.27 million people worldwide died due to antimicrobial resistance. Without international efforts to tackle this problem, it is predicted that by 2050, over 10 million people could die each year as a result of AMR, with the cumulative economic impact potentially reaching up to 100 trillion USD.