To treat influenza FDA approved a new drug
- Post By : Khushboo Sharma
- Source: FDA
- Date: 02 November, 2018
The U.S FDA administration has recently approved a new drug for the treatment of influenza (Flu). This drug Xofluza (baloxavirmarboxil) will be used for the treatment of the acute uncomplicated influenza (flu) in patients who are currently 12 years and older who have been symptomatic for no more than 48 hours.
Flu is usually caused by the influenza viruses in which the patient who is suffering from flu gets treatment within 48 hours of becoming sick, flu is a contagious respiratory illness therefore anyantiviral drugs can reduce symptoms and duration of the illness.
The FDA commissioner Scott gottlied, M.D.said that "This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,". "While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination.
Flu season is already well underway, and the U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks."
"When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick," said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research. "Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs."
There were two randomized controlled clinical trials of 1,832 patients’ participants who were assigned to receive either he Xofluza, a placebo or another antiviral flu treatment within 48 hours of the experiencing flu symptoms. The safety and efficacy of Xofluza, an antiviral drug taken as a single oral dose, in both the trials, those patients who were treated with Xofluza were having the shorter time to alleviation of symptoms in a comparison with other patients who were treated with the placebo. In the second trial there was no difference found in the time of alleviation of the symptoms between the subjects who received the Xofluza and those who received the other flu treatment.
The very common adverse reaction which was received from the patients who received the Xofluza was including diarrhea and bronchitis.
Xofluza was granted the priority received under which the FDA’s goal is to take the action on an application inside an expedited time frame where the agency has to determine the drug, that if it gets approved then will it significantly improve the safety of 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 health by assuring the safety, effectiveness, security of human 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, products that give off electronic radiation, and for regulating tobacco products.