FDA Approves New Single-dose Treatment For Influenza

October 24th, 2018

On October 24, 2018, the FDA approved XOFLUZA™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza in people 12 years of age and older. XOFLUZA is the first and only single-dose oral antiviral medicine with a novel proposed mechanism of action approved to treat the flu.

News in brief

• XOFLUZA is the first and only single-dose oral medicine approved by the FDA to treat the flu, and is the first new flu medicine with a novel proposed mechanism of action approved in nearly 20 years.
• Patients now have a convenient treatment option that reduces flu symptoms by more than a day with a single oral dose. If patients see their doctors within 48 hours of symptom onset, a single dose of XOFLUZA can significantly reduce the duration of flu symptoms.
• New treatment options for the flu are important. Each year, an estimated 3-11 percent of the U.S. population gets the flu, and it can be very serious, resulting in hospitalization or even death. Since 2010, the Centers for Disease Control and Prevention (CDC) estimates that the flu has resulted annually in 9.2 to 35.6 million illnesses, 140,000 to 900,000 hospitalizations and 12,000 to 80,000 deaths.

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