Ping An-Shionogi Submits New Drug Application for Cefiderocol in China
Tuesday, August 06, 2024
Shionogi announced that Ping An-Shionogi has submitted a New Drug Application (NDA) for cefiderocol to the Center for Drug Evaluation (CDE) of the NMPA in China. This application has now been accepted for review.
Cefiderocol is an innovative antibiotic that effectively penetrates the outer membrane of gram-negative bacteria, including those resistant to multiple drugs, demonstrating strong antimicrobial properties. It is already available in over 10 countries and regions, including Japan, Europe, and the United States, playing a crucial role in treating infections caused by drug-resistant bacteria. Additionally, cefiderocol is in clinical use at the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, China.
Antimicrobial resistance (AMR), which involves bacteria becoming resistant to antibiotics, is a significant global public health threat. Addressing this urgent issue on an international scale is crucial. In China alone, it was estimated that in 2019, AMR was directly responsible for 145,500 deaths and associated with 602,600 deaths. These figures are believed to have increased since then.
The current NDA is supported by positive results from a Phase III clinical trial involving 150 patients with complicated urinary tract infections in China. In this trial, cefiderocol showed superior efficacy compared to the comparator drug, imipenem/cilastatin, with no new safety concerns reported.
Source: shionogi.com
