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FDA approves the first flu drug in nearly 20 years Author : admin / release time : 26 11月,2020

Recently, the US Food and Drug Administration announced that Xofluza, a new anti-influenza drug, was approved for marketing. The drug is mainly used to treat acute influenza patients over 12 years old and whose flu symptoms last no more than 48 hours. This is the first anti-influenza drug with an innovative mechanism of action approved by the FDA in the past 20 years.

  Xofluza was jointly developed by Shionoyoshi Pharmaceutical Co., Ltd. and Roche Pharmaceutical Co., Ltd., is an oral antiviral drug that can be effective after only one dose.

  The approval is based on the results of two studies conducted by scientists on more than 1,800 people. Participants took Xofluza or a placebo, Xofluza or different antiviral flu drugs.

  Compared with patients who took placebo, patients who took Xofluza within 48 hours after the onset of flu symptoms had a significantly shorter time to relief and duration of symptoms after taking the drug. And the time for patients to release the virus is also significantly shortened, which helps control the spread of influenza. The second study found that Xofluza is as effective as other antiviral drugs in treating influenza.

  The drug works by inhibiting the polymerase acid endonuclease in the influenza virus. In the process of influenza virus replication, it must rely on this enzyme. This is different from other flu medicines. For example, the antiviral drug Tamiflu (oseltamivir phosphate) works by blocking neuraminidase, another enzyme required for virus replication.

  Obviously, Xofluza targets an earlier stage of the viral replication cycle compared to other drugs.

  FDA Commissioner Dr. Scott Gottlieb said in a statement: "This is the first new antiviral flu therapy with an innovative mechanism of action approved by the FDA in the past 20 years. Thousands of people are infected with influenza every year, and Influenza viruses can develop resistance to antiviral drugs, so safe and effective treatment options are essential. This new drug provides an important additional treatment option."

  However, the FDA also emphasized that Xofluza and other antiviral drugs cannot replace seasonal influenza vaccines. "Annual vaccination is the main means to prevent and control influenza outbreaks."

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