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    Home > Medical News > Medical World News > Japan urgently approved the first oral drug made in Japan

    Japan urgently approved the first oral drug made in Japan

    • Last Update: 2023-01-05
    • Source: Internet
    • Author: User
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    Japan's Ministry of Health, Labor and Welfare urgently approved a Japanese-made new crown oral drug on the 22nd, which is the first drug
    approved after Japan established a relevant emergency approval system in May this year.
     
    The tablet called XOCOVA developed by Shionogi Pharmaceutical Company of Japan was approved on the same day, and its active ingredient was ensetivir fumarate
    .
    According to the press release released by the Ministry of Health, Labor and Welfare on the same day, this drug was approved for use in people over 12 years old with new crown infection, once a day for 5 days
    .
     
    The communiqué said the drug inhibited viral replication
    by affecting the 3CL protease of the new coronavirus.
    In clinical trials, it can effectively shorten the time required for symptoms such as fatigue, fever, nasal discharge or nasal congestion, sore throat, and cough in people infected with the new
    crown to disappear.
     
    Japan's previously approved new crown oral drugs include the Pfizer nematevir/ritonavir combination (Paxlovid) and Merck's monabigravir
    .
    However, these two drugs are only allowed to be used in groups at high risk of severe disease such as elderly new crown patients, and XOCOVA has no similar restrictions and has received widespread attention
    .
     
    According to the relevant emergency approval system established in Japan in May this year, after the emergency approval of a drug, its manufacturer and seller must continue clinical trials to further confirm the effectiveness and safety of the drug, and apply for approval
    again within two years.
    If efficacy and safety are not confirmed, approval may be revoked
    .
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