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    Home > Active Ingredient News > Drugs Articles > Super flu medicine! Yannoyi Xofluza was approved in Taiwan, China: the first single dose of influenza medicine for post-exposure probiotics!

    Super flu medicine! Yannoyi Xofluza was approved in Taiwan, China: the first single dose of influenza medicine for post-exposure probiotics!

    • Last Update: 2021-01-27
    • Source: Internet
    • Author: User
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    Shionogi, a Japanese drug company, recently announced that an application for a new supplement to its flu drug, baloxavir marboxil, has been approved in Taiwan, China, for use in people aged 12 and over who have been exposed to influenza as a preventive treatment for influenza, or post-exposure prophylactic treatment.
    it is worth noting that Xofluza is the first single dose of influenza drug approved for post-exposure proctising.
    previously, Xofluza was approved in August 2019 in Taiwan, China, for the treatment of acute influenza A and B virus infections in children and adults 12 years and older.
    in clinical studies, Xofluza's single treatment significantly reduced the duration of flu symptoms and significantly reduced virus release within a day of taking it.
    Xofluza is the first and only single-dose oral drug approved for flu treatment and the first new flu drug with a new mechanism of action in nearly 20 years.
    the drug is a kernel-cut nuclease inhibitor designed to suppress cap hat structure-dependent keratase in influenza viruses, which is essential for the replication of influenza viruses.
    Xofluza is designed to fight influenza A and B viruses, including the drug-resistant strains of dafi (oseltamivir, oseltamivir) and avian influenza (H7N9, H5N1).
    Xofluza was discovered by Yannoyi and developed globally by Roche and Yannoyi.
    the agreement, Roche has global rights to the drug, except in Japan and Taiwan, China.
    so far, Xofluza has been approved in more than 30 countries for the treatment of influenza A and B.
    Approved adaptations to the drug include: (1) for ≥ healthy 12-year-olds or high-risk groups with severe influenza-related complications, treatment of acute, non-complex influenza with symptoms of no more than 48 hours, and (2) for ≥12-year-olds for preventive treatment after influenza exposure.
    strong clinical evidence suggests that Xofluza has therapeutic benefits for multiple populations (healthy influenza populations, high-risk groups for flu complications, children) and the treatment environment (symptom flu, post-exposure pro- and post-exposure prevention).
    , Xofluza is currently being evaluated in a Phase III clinical development project, including a group of children under one year of age (NCT03653364), hospitalizations for severe influenza (NCT03684044) and an assessment of the likelihood of reducing the spread of influenza from infected persons to healthy people (NCT0396912).
    post-exposure probation approval, based on the results of the Phase 3 BLOCKSTONE study, which evaluated the post-exposure probing effects of single-dose Xofluza.
    findings were recently published in the New England Journal of Medicine (NEJM).
    BLOCKSTONE evaluated Xofluza and placebo as preventive treatment for family members (adults and children) living with influenza patients.
    data show that Xofluza as a single-dose oral drug has a significant preventive effect against influenza in family contacts with influenza patients compared to placebo.
    subjects treated with Xofluza, 1.9 per cent of family members aged 12 and over had influenza and 13.6 per cent in the placebo group.
    the study, Xofluza was well-to-do and no new safety signals were found.
    BLOCKSTONE study is a randomized, placebo-controlled, post-exposure prevention study that included healthy subjects (adults and children) whose family members were confirmed as influenza-infected by rapid influenza diagnostic tests (i.e., "indicated cases").
    subjects were randomly assigned a single dose of Xofluza (dose based on weight) or a placebo as a precaution against influenza.
    end point is to assess the proportion of subjects who tested positive for influenza virus, had a fever, and had one or more respiratory symptoms during the observation period 1-10.
    results showed that a single oral Xofluza had a significant role in preventing influenza infection and significantly reduced the risk of influenza by 86 percent among healthy subjects with influenza in their family members.
    specific data were: a significant decrease in the proportion of subjects with influenza infection in the Xofluza group compared to the placebo group (1.9% vs. 13.6%, p<0.0001) of subjects with influenza virus infection, fever and other flu symptoms during the 10-day observation period.
    regardless of the influenza A subtype, the therapeutic benefits of Xofluza are still statistically significant compared to placebo (H1N1 subtype: 1.1% vs. 10.6%, p=0.0023; H3 subtype: 2.8% vs. 17.5%, p<0.0001).
    also observed in family contacts (2.2% vs 15.4%, p-0.0435) and children under 12 years of age (4.2% vs 15.5%, p-0.0339) who were at higher risk of influenza-related complications.
    The study also showed that Xofluza significantly reduced a family member's risk of influenza by 76 percent (3 percent vs. 22.4 percent, p<0.0001) compared to a placebo, even with fewer flu criteria (the percentage of participants with flu, fever, or one or more respiratory symptoms).
    study, Xofuza was as safe as a placebo, with a 22.2 percent adverse event rate in the Xofuza group and 20.5 percent in the placebo group.
    Xofuza has no reports of serious adverse events.
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