Updated
October 21st, 2019

Xofluza Approved for People at High Risk of Developing Influenza-Related Complications

Flu shots are an important first line of defense in preventing influenza

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Genentech announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for Xofluza™ for the treatment of acute, uncomplicated influenza 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.

Although flu vaccines are an important first line of defense in preventing the flu, there is a need for new medical options for prophylaxis and treatment, said Genentech.

Xofluza (baloxavir marboxil) is a first-in-class, 1-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.

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, representing the first new antiviral to treat the flu in the U.S. in 20 years.

This expanded indication for Xofluza was approved based on results from the Phase III CAPSTONE-2 study of a single dose of 40 mg or 80 mg of Xofluza compared to oseltamivir (75 mg twice daily for five days), or placebo in people 12 years of age or older who met the criteria for being at high risk of complications from the flu. 

Xofluza significantly reduced the time to improvement of flu symptoms compared to placebo, including in people infected with the flu type B virus. Adverse events reported in at least 1% of adult and adolescent subjects treated with Xofluza included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%) and headache (1%).

Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, said in a October 17, 2019, press release, “People with chronic conditions such as asthma, heart disease, and diabetes are at higher risk of developing serious complications from the flu, so it is critical that these patients speak with their healthcare providers about possible treatment at the first signs and symptoms of the disease.”

Important Safety Information

  • Do not take XOFLUZA if you are allergic to baloxavir marboxil or any of the ingredients in XOFLUZA.
  • Before you take XOFLUZA, tell your healthcare provider about all of your medical conditions, including if you:
  • Are pregnant or plan to become pregnant. It is not known if XOFLUZA can harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if XOFLUZA passes into your breast milk.

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The Centers for Disease Control and Prevention (CDC) defines people at high risk of serious flu complications as those who have conditions such as asthma, chronic lung disease, diabetes, heart disease, morbid obesity or adults 65 years of age or older.

Influenza, or flu, is one of the most common, yet serious, infectious diseases, representing a significant threat to public health. Since 2010, the CDC estimates that the flu has resulted annually in 9.3 to 49 million illnesses, 140,000 to 960,000 hospitalizations and 12,000 to 79,000 deaths.

Other antiviral medicines have limitations with respect to efficacy, the convenience of dosing and resistance. Genentech is committed to addressing the unmet need in this area through its agreement with Shionogi & Co., Ltd. to develop and commercialize Xofluza.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. For additional information about the company, please visit Genentech.

Influenza news published by Precision Vaccinations