The US Food and Drug Administration (FDA) has approved Shionogi’s Fetroja (cefiderocol) for certain patients with complicated urinary tract infections (cUTI).
The organisation approved the treatment for patients 18 years of age or older who have limited or no alternative options, based on limited clinical safety and efficacy data for the drug.
The decision was made off the back of data from the pivotal APEKS-cUTI study, a multinational, multicenter, double-blind clinical trial that evaluated the efficacy and safety of the therapy compared to imipenem/cilastatin (sold under the brand name Primaxin among others).
The positive results showed that 72.6% of patients in the Fetroja arm met the primary endpoint, compared to 54.6% in the IPM/CS arm.
The drug will “fill a very important unmet medical need because of its unique method of penetrating the cell wall of Gram-negative bacteria and its ability to overcome many of the resistance mechanisms that bacteria employ against antibiotics” explained Isao Teshirogi, president and CEO at Shionogi.
He continued to say, “Today’s approval represents Shionogi’s ongoing commitment to develop medicines that help fight these life-threatening infections in patients for whom limited or no alternative treatment options exist.”
Shionogi has also submitted a marketing authorisation application for the drug to the European Medicines Agency and it was accepted in March 2019.