FDA approves expanded indication for Roche's Xofluza

Roche has received the Food and Drug Administration’s green light for Xofluza (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications. Xofluza is a first-in-class, one-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.

“With flu season rapidly approaching, we can now offer Xofluza as the first and only FDA approved treatment option indicated specifically for those at high risk of flu complications,” said Levi Garraway,  Roche’s chief medical officer and head of global product development. “People with chronic conditions such as asthma, heart disease and diabetes are at higher risk of developing serious complications from flu, so it is critical that these patients speak with their healthcare providers about possible treatment at the first signs and symptoms of the disease.”

Flu has the potential to cause a variety of complications, ranging from sinus or ear infections to more serious complications such as pneumonia.

In October 2018, Xofluza was first approved by the FDA for the treatment of acute, uncomplicated flu in otherwise healthy people 12 years of age and older who have been symptomatic for no more than 48 hours, representing the first new antiviral to treat influenza in the United States in 20 years.