FDA accepts new application for Xofluza for the treatment of influenza in people at high risk of complications

Genentech, a member of the Roche Group announced that the FDA has accepted a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) as a single-dose, oral treatment for people at high risk of complications from the flu. The Centers for Disease Control and Prevention (CDC) defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity or heart disease. The FDA is expected to make a decision on approval by November 4, 2019

The sNDA is based on results from the Phase III CAPSTONE-2 study of a single dose of Xofluza compared with placebo or oseltamivir 75 mg, twice daily for five days, in people 12 years of age or older who are at high risk of complications from the flu. The FDA approved Xofluza in October 2018 for the treatment of acute, uncomplicated influenza in people 12 years of age or older. It is the first and only single-dose oral medicine approved to treat the flu, and the first new flu medicine with a novel proposed mechanism of action in nearly 20 years.