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Roche: FDA Approves Xofluza To Treat Influenza In People With High Risk

Swiss drug major Roche Group (RHHBY) announced that the US Food and Drug Administration has approved a supplemental New Drug Application or sNDA for Xofluza (baloxavir marboxil) for people at high risk of developing influenza-related complications.

The approval is for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications.

Xofluza is a first-in-class, one-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.

The company noted that single-dose Xofluza is the first and only FDA-approved antiviral medicine indicated specifically for those at high risk of flu complications.

Xofluza is currently approved in several countries to treat influenza types A and B. In October 2018, Xofluza was first approved by the FDA for the treatment of acute, uncomplicated flu in otherwise healthy people 12 years of age and older who have been symptomatic for no more than 48 hours. It is the first new antiviral to treat influenza in the United States in 20 years.

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