The US Food and Drug Administration (FDA) has approved a new single-dose flu treatment called Xofluza, also known as baloxavir marboxil. Xofluza is a pill developed by the Roche Group and Shionogi & Co. that can reduce the severity and duration of flu symptoms after a single dose.
Xofluza is the first new type of flu drug approved in two decades. Roche has the rights to market Xofluza everywhere but Japan and Taiwan. It will cost $150 without insurance and will launch within a few weeks. Xofluza has been approved for people age 12 and older.
Xofluza is said to work about as well as Tamiflu, Roche’s older flu treatment. Both treatments have been found to greatly reduce flu symptoms in about two days on average. Xofluza was found to reduce the level of the virus in patients’ nose and throat faster than Tamiflu. Xofluza side effects were mild and occurred at about the same rate as Tamiflu.
FDA Commissioner Dr. Scott Gottlieb said in a statement, “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.”
The approval of the new drug comes ahead of the brunt of this winter’s flu season. Flu treatments generally work best if taken within 48 hours of symptoms beginning.
The Centers for Disease Control and Prevention reports that only 37 percent of Americans got vaccinated for the flu last year. That was a 6.2 percent drop in vaccination from the previous season.
An estimated 80,000 Americans died of flu and its complications last winter, according to health officials. That was the highest death toll for the disease in at least forty years. The flu typically kills about 12,000 to 56,000 Americans annually.