SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of the Roche Group (RHHBY), announced the U.S. 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 FDA is expected to make a decision on approval by November 4, 2019.
The FDA approved XOFLUZA in October 2018 for the treatment of acute, uncomplicated influenza in people 12 years of age or older.
XOFLUZA was discovered by Shionogi & Co., Ltd. and is being further developed and commercialized globally in collaboration with the Roche Group (which includes Genentech in the U.S.) and Shionogi & Co. Roche holds worldwide rights to XOFLUZA excluding Japan and Taiwan.
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