Japanese drugmaker Shionogi announced today that the Taiwan Food and Drug Administration (TFDA) will review its New Drug Application (NDA) for the novel antibiotic cefiderocol.
Cefiderocol is a cephalosorin antibiotic with a novel method of penetrating the tough outer membrane of gram-negative bacteria, including strains that are resistant to several other antibiotics, and is considered an important treatment option against multidrug-resistant infections. The NDA submitted to the TFDA is for treatment of infections due to aerobic gram-negative bacteria in adult patients who have limited treatment options.
The drug is already approved and marketed in the United States and Europe, but the company says it is now focusing on getting it approved in Taiwan, Japan, China, and other countries.
In June, Shionogi announced a partnership with the Global Antibiotic Research and Development Partnership and the Clinton Health Access Initiative to expand access to cefiderocol in low- and middle-income countries where antimicrobial resistance (AMR) is rising and treatment options for resistant infections are limited.
"Shionogi is committed to overcoming the global AMR problem and to rapidly providing infectious disease drugs required to protect the health of patients around the world through various collaborations," the company said in a press release.