The Korean government has approved a phase-3 clinical trial to evaluate the efficacy and safety of a new influenza treatment baloxavir marboxir (product name: Xofluza).

The Ministry of Food and Drug Safety on Wednesday gave the nod to check whether would be safe and effective to use baloxavir marboxir in patients hospitalized with severe influenza, compared to the standard treatment using neuraminidase inhibitors.

The trial will take place at Catholic University of Incheon St. Mary's Hospital, Kyungpook National University Hospital, Korea University Anam Hospital and Guro Hospital, Samsung Medical Center, Asan Medical Center, Chung-Ang University Hospital, Kangnam Sacred Heart Hospital, Wonju Severance Christian Hospital, Chungnam National University Hospital, and Bundang Seoul National University Hospital.

As a follow-up drug of Tamiflu, Roche jointly developed baloxavir marboxir with Japan’s Shionogi Co. The new medicine treats Tamiflu-resistant patients infected with influenza A and B.

In two clinical trials where 1,823 patients participated, those treated with baloxavir marboxir showed quicker improvement in symptoms than the placebo-given control group.

Unlike Tamiflu which needs to be taken twice a day for five days, baloxavir marboxir can be taken once daily. The most common side effects of baloxavir marboxir are diarrhea and bronchitis.

The U.S. Food and Drug Administration gave the green light to baloxavir marboxir under the product labeling of Xofluza in October 2018.

lhs@docdocdoc.co.kr

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