• FDA Approves Shionogi’s cUTI Medicine Following Positive Advisory Support

    • November 16, 2019
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    The U.S. Food and Drug Administration (FDA) approved Shionogis Fetroja as a treatment for adult patients with complicated urinary tract infections caused by a number of Gram-negative microorganisms.

    The approval came only a few days after the U.S. Centers for Disease Control and Prevention issued a report that antibiotic-resistant infections have grown significantly in the United States over the past six years. The CDC said more than 2.8 million antibiotic-resistant infections annually occurred in the U.S., leading to the deaths of more than 35,000 people. Of those deaths, Clostridioides difficile (C. diff) infections resulted in nearly half, with 12,800 deaths.

    John Farley, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said the growing threat antimicrobial-resistant infections is a key challenge for the regulatory agency. The approval of Fetroja “represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” Farley said in a statement.

    The approval of Fetroja marks the first antibiotic to function as siderophore, a molecule that transports iron into microorganisms. Once inside the bacteria, Fetroja is stable against all known classes of beta-lactamases. Fetroja addresses many of the resistance mechanisms that bacteria employ against antibiotics, the company said.

    Fetroja was approved under Fast Track Designation and Priority Review and is expected to be commercially available in early 2020. Isao Teshirogi, president and chief executive officer of Japan-based Shionogi, said the approval of Fetroja will fill an important unmet medical need due to its “unique method” of penetrating the cell wall of Gram-negative bacteria. Those Gram-negative microorganisms specifically indicated for Fetroja’s use by the FDA include Escherichia coli, Klebsiella pneumonia, Proteus mirabilis, Pseudomonas aeruginosa and Enterobacter cloacae complex. Teshirogi also pointed to the drug’s ability to “overcome” many of the resistance mechanisms that bacteria employ against antibiotics.

    “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,” Teshirogi said in a statement.


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