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EThe United States Food and Drug Administration (FDA) yesterday Has agreed to sell its first drug, Xofluza, from Roche, containing the active ingredient (baloxavir marboxil) to treat uncomplicated acute influenza in patients 12 years of age and older who have been exposed to the disease for up to 48 hours.
The statement pointed out the possible side effects of this medicine, such as bronchitis and severe diarrhea.
"This drug is the first new treatment for resistance to influenza for nearly 20 years with a new mechanism approved by the Food and Drug Administration," said Commissioner Scott Gottlieb, of the Food and Drug Administration.
The FDA approval was based on the results of two studies involving more than 1,800 people. One study found that patients treated with Xofluza within 48 hours of onset of flu symptoms had decreased their symptoms faster than those in the placebo group.
According to these studies, the new drug binds a necessary enzyme to the influenza virus, different from the enzyme targeted by the antivirus Tamiflu.
"It's important to have more treatment options that attack the virus in different ways because influenza viruses can become resistant to antiretroviral drugs," said Dr. Debra Berenkrant, Director of Antiviral Drugs at the University of Toronto. Food and Drug Administration.
Berenkrant pointed out that the drug did not replace a dose of seasonal influenza vaccine, and said that "annual vaccination is the primary means of preventing and controlling the flu epidemic".
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