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FDA: Influenza Medication Receives Expanded Approval

October 17, 2019

According to a recent press release, the FDA has approved single-dose Xofluza (baloxavir marboxil; Genetench) for the treatment of acute, uncomplicated influenza, or flu, in patients 12 years of age and older who are at high risk of developing flu-related complications. 

“With the flu season rapidly approaching, we can now offer Xofluza as the first and only FDA-approved treatment option indicated specifically for those at high risk of flu complications,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a press release. 

The safety and efficacy of the treatment was evaluated during a Phase III, multicenter, randomized, double-blind. During the study, a single dose of Xofluza was compared with placebo and oseltamivir in participants 12 years of age or older who are at a high risk of complications from the flu. Participants were randomly assigned to receive either Xofluza (40 mg or 80 mg), placebo, or 75 mg of oseltamivir twice daily for 5 days. According to the findings, Xofluza reduced the time to improvement of flu symptoms. Further, it showed similar efficacy to oseltamivir in the reduction of duration of symptoms.  

The most commonly reported side effects include: 

  • diarrhea;
  • bronchitis;
  • sinusitis;
  • headache; and
  • nausea.  

As of October 2018, Xofluza is approved for the treatment of acute, uncomplicated flu in otherwise healthy individuals aged 12 years and older. However, it is unknown if the treatment is both safe and effective in children younger than 12 years of age or weighing less than 88 pounds. 

“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,” Dr Garraway noted. 

Julie Gould  


Genentech. Genentech announced FDA approval of Xofluza (baloxavir marboxil) for people at high risk of developing influenza-related complications [press release]. Accessed October 17, 2019.

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