October 24, 2018

The Food and Drug Administration (click here) on Wednesday approved a new, single-dose flu medication to treat people 12 and older who have had the flu for no more than 48 hours.

Baloxavir, to be sold by Genentech under the brand name Xofluza, is the only single-dose oral medicine approved to treat the flu. It has been shown to significantly reduce the duration of symptoms.

It's expected to be available within weeks. 

The announcement comes at the outset of the 2018-19 flu season, after the deadliest season in four decades. More than 80,000 people died from the flu in the United States in 2017-18 and 900,000 were hospitalized, according to the Centers for Disease Control and Prevention.

Xofluza is the first new flu medicine with a novel proposed mechanism of action approved in nearly 20 years, FDA Commissioner Scott Gottlieb said.

"With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical," said Gottlieb, a physician....