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.
“In both trials, patients treated with Xofluza had a shorter time to alleviation of symptoms compared with patients who took the placebo. In the second trial, there was no difference in the time to alleviation of symptoms between subjects who received Xofluza and those who received the other flu treatment,” FDA said.
Commissioner Scott Gottlieb added: “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.”
Influenza Virus Vaccine for the 2018-2019 Season
Novel Drug Approvals for 2018