Roche announced that the phase III BLOCKSTONE study, conducted by Shionogi & Co., Ltd., met its primary endpoint showing that people exposed to a household member with influenza (flu) and treated preventively with Xofluza™ (baloxavir marboxil) were significantly less likely to develop the disease compared to those treated with placebo (1.9% versus 13.6%, p<0.0001). Furthermore, Xofluza was well tolerated with no safety signals identified. Full results from the BLOCKSTONE study will be presented at an upcoming medical meeting.
“This positive phase III study adds to robust existing clinical data for Xofluza, and is the first to show that a single treatment with Xofluza reduced the likelihood that people living with an infected household member would develop flu,”
said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development.
“Preventing otherwise healthy people from developing the flu virus will reduce the overall societal burden of disease, and we look forward to sharing these data with health authorities around the world.”
Xofluza is the first and only one-dose oral medicine approved to treat flu, and the first new flu medicine with a novel proposed mechanism of action in nearly 20 years. Xofluza is also the only flu treatment with a new mechanism of action shown to be efficacious in both otherwise healthy people with the flu (in the CAPSTONE-1 study), and people at high risk of flu complications (in the CAPSTONE-2 study).
Xofluza is currently approved in Japan for the treatment of influenza types A and B in children, adolescents and adults, and in the United States (US) for the treatment of acute, uncomplicated influenza in people 12 years of age and older. In addition, the FDA recently accepted a supplemental New Drug Application (sNDA) for Xofluza as a one-dose oral treatment for people at high risk of complications from the flu, which includes adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity or heart disease – for these people the flu can be particularly serious or deadly. The FDA is expected to decide on whether to approve this additional indication by 4 November 2019.