Genentech’s Xofluza (baloxavir marboxil) has been granted US Food and Drug Administration (FDA) approval for a supplemental New Drug Application (NDA).
The approval has been approved for the indication of acute, uncomplicated influenza, or flu, in people 12 and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications.
The approval marks the drug as the first and only antiviral medicine indicated specifically for patients at high risk of developing serious complications from the flu, and was approved based on results from the Phase III CAPSTONE-2 study, which included people 12 years and older who met the CDC criteria for being at high risk of complications from the flu.
“With the 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,” announced Levi Garraway, MD, 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 the 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.”
The “first-in-class, one-dose oral medicine” has a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.
People at high risk of serious flu complications – those who will benefit from the drug - have conditions such as asthma, chronic lung disease, diabetes, heart disease, morbid obesity or adults 65 years of age or older, as defined by The Centers for Disease Control and Prevention (CDC).
Xofluza is currently already approved in several countries for the treatment of flu types A and B.