Roche's Xofluza Wins Expanded FDA Approval To Treat Influenza In Kids Aged Five Years And Older

The FDA has approved the expanded use of Roche Holding AG's (RHHBY) single-dose flu drug Xofluza to treat acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for not more than two days.

In addition, the regulator has also approved Xofluza for the prevention of influenza in children in the same age group following contact with someone with influenza.

Xofluza is the first and only single-dose oral influenza drug approved in the U.S. for kids as young as five.

The drug is already approved in the U.S. to treat influenza in people 12 years of age and older and to prevent influenza in people 12 years of age and older following contact with someone with influenza.

During the 2018-19 influenza season in the U.S., there were over 6 million illnesses, thousands of hospitalizations, and over 100 deaths among children aged five to 17 caused by influenza.

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