US COPD Coalition

FDA Approves New Influenza Drug


The U.S. Food & Drug Administration (FDA) has just announced the approval of a new drug to treat influenza. The drug, Xofluza (baloxavir marboxil), is approved to be used for individuals who are 12 years of age and older and who have had flu symptoms for less than 48 hours.

‘This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. 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,” said FDA Commissioner Scott Gottlieb, M.D. While the approval of Xofluza is an exciting advancement in the treatment of influenza, Dr. Gottlieb stressed the importance of annual flu vaccines as a firstline defense against the flu. “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. Yearly vaccination is the primary means of preventing and controlling flu outbreaks.”

Read the FDA’s full press announcement here.