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Today, the U.S. Food and Drug Administration approved Xofluza (Baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no longer than 48 hours.
"This is the first new antiviral treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting fluent every day, and many people getting serious ill, having safe and effective treatment is critical. This new drug provides an important, additional treatment option, "said FDA Commissioner Scott Gottlieb, MD." While there are several FDA-approved antiviral drugs to treat flu, they are not a substitute for annual vaccination. Flu season is already well underway, and the US Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as the flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks. "
Flu is a contagious respiratory illness caused by influenza viruses. When patients with the disease become infected, antiviral drugs can reduce symptoms and duration of illness.
"When treatment is started within 48 hours of becoming sick," said Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA 's Center for Drug Evaluation and Disease. Research. "Having more treatment options is important because viruses can be resistant to antiviral drugs."
The safety and efficacy of Xofluza, an antiviral drug taken as a single oral dose, was demonstrated in two randomized controlled clinical trials of 1,832 patients where Xofluza, placebo, or other antiviral treatment was received in 48 hours of experiencing flu symptoms. In both trials, patients treated with Xofluza had a short time to alleviation of symptoms compared with patients who took the placebo. In the second trial, there is no difference in the time of receipt of the disease.
The most common adverse reactions in patients with Xofluza included diarrhea and bronchitis.
Xofluza has been granted Priority Review under which the FDA 's goal is to take action on an application within an expedited time frame where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
The FDA granted approval of Xofluza to Shionogi & Co., Ltd.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public by the safety, effectiveness, safety, and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, and other products.
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