USA – FDA Approves Anti-Flu Pill – First New Treatment in Nearly 20 Years

The US Food and Drug Administration (FDA) on Wednesday approved Japanese company Shionogi’s flu treatment Xofluza (baloxavir marboxil) – the first new antiviral flu treatment with a novel mechanism of action approved by FDA in nearly 20 years.

The pill is indicated 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.

Globally, annual flu epidemics result in three to five million cases of severe disease, millions of hospitalizations and as many as 650,000 deaths worldwide.

The safety and efficacy of Xofluza  was demonstrated in two randomized controlled clinical trials of 1,832 patients where participants were assigned to receive either Xofluza, a placebo or another antiviral flu treatment within 48 hours of experiencing flu symptoms…