On Oct. 17, 2019, Genentech announced the U.S. Food and Drug Administration (FDA) had approved Xofluza (Baloxavir Marboxil), the first and only antiviral medicine indicated specifically for patients at high risk of developing serious complications from influenza (flu).

This expanded indication for Xofluza was approved based on results from the Phase III CAPSTONE-2 study of a single dose of 40 mg or 80 mg of Xofluza compared to oseltamivir (75 mg twice daily for five days), or placebo in people 12 years of age or older who met CDC criteria for being at high risk of complications from the flu.

Xofluza significantly reduced the time to improvement of flu symptoms compared to placebo, including in people infected with the flu type B virus.