FDA approves the first flu drug listing in the past 20 years

FDA approves the first flu drug listing in the past 20 years

October 26, 2018 Source: Science and Technology Daily

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Science and Technology Daily, Beijing, October 25 (Reporter Liu Xia) According to the US Fun Science website, the US Food and Drug Administration (FDA) announced on the 24th that it has approved the new anti-influenza drug Xofluza for the treatment of flu symptoms over 12 years old. Acute influenza patients who do not last longer 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.

Developed by Japan's Yan Yeyi Pharmaceutical Co., Ltd. and Roche Pharmaceuticals Co., Ltd., Xofluza is an oral antiviral drug that is effective only once.

The approval was based on two studies conducted by scientists on more than 1,800 people who took Xofluza or placebo, Xofluza or different antiviral flu medications.

Compared with patients taking placebo, patients taking Xofluza within 48 hours after the onset of flu symptoms, the time to symptom reduction and the duration of symptoms were significantly shortened after taking the drug. And the time it takes for patients to release the virus is significantly reduced, which helps control the spread of the flu. The second study found that Xofluza is as effective in treating the flu as other antiviral drugs.

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

Clearly, Xofluza targets earlier stages of the viral replication cycle than other drugs.

FDA Director Dr. Scott Gottlieb said in a statement: "This is the first new antiviral flu therapy with an innovative mechanism approved by the FDA in the past 20 years. Thousands of people are infected with the flu every year, and Influenza viruses can be resistant to antiviral drugs, so a safe and effective treatment plan is essential, and this new drug offers an important additional treatment option."

However, the FDA also stressed that Xofluza and other antiviral drugs are not a substitute for seasonal flu vaccines. "Annual vaccination is the primary means of preventing and controlling influenza outbreaks."

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