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Genentech : Late-stage Study Shows Xofluza Prevents Influenza Infection

Genentech, a member of the Roche Group (RHHBY), said Tuesday that Phase III study, dubbed BLOCKSTONE, showed Xofluza was effective at preventing influenza infection.

The company noted that the late-stage Blockstone study, conducted by Shionogi & Co., met its primary endpoint showing that people exposed to a household member with influenza and treated preventatively with Xofluza were significantly less likely to develop the disease compared to those treated with placebo. In addition, Xofluza was well tolerated with no safety signals identified.

Xofluza is currently approved in Japan for the treatment of influenza types A and B in children, adolescents and adults, and in the U.S. for the treatment of acute, uncomplicated influenza in people 12 years of age and older.

Recently, the U.S. Food and Drug Administration accepted a supplemental New Drug Application 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.

It is expected that the FDA will decide on whether to approve the additional indication by November 4, 2019.

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