The USFDA 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 more than 48 hours.
This is the first newly antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years.
This is the first newly antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting infected by flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This New drug provides an important, additional treatment optionFDA Commissioner Scott Gottlieb, M.D.
While there are many FDA-approved antiviral drugs to treat flu, but they’re not a substitute for yearly vaccination.
Flu season is very near, 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 best effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can be result in hospitalizations.
Yearly vaccination is the primary and basic means of preventing and controlling flu outbreaks.
When treatment is started between 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 for Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.
Having more treatment options that work in different ways to kill the virus is important because flu viruses can become resistant towards the antiviral drugs.
The safety and efficacy of Xofluza antiviral drug can be taken as a single oral dose, was demonstrated in two randomized controlled clinical trials of 1,832 numbers of patients where they were assigned to receive either Xofluza, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms.
In both trials, patients treated with Xofluza drug had a shorter time to alleviation of symptoms compared with patients who took the placebo.
In the second trial, there was no difference found in the time to alleviation of symptoms between subjects who received Xofluza and those who received the other flu treatment.
The most common adverse reactions reported in patients taking Xofluza included..
Xofluza was granted Priority Review under which the Food and Drug Administration’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 serious conditions.
The FDA granted approval of Xofluza Drug to Shionogi & Co., Ltd.