FDA Approves Fast-Acting, Single-Dose Flu Medication

After the deadly 2017-18 influenza (flu) season in the U.S., the U.S. Food and Drug Administration (FDA) has approved a new, single-dose medication to treat people 12 years and older who have had the flu for no more than 48 hours. Baloxavir (Xofluza) is the only single-dose oral medication approved to treat the flu. According to Genentech, if patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms. “Although there is no substitute for the flu vaccine, we appreciate the development of any medication that assists in the treatment of influenza,” said Rebekah Gee, MD, secretary of the Louisiana Department of Health. “These medications can be lifesaving for those seriously ill, and the single dose makes it a much easier treatment to complete.”

Approval was based on two randomized controlled clinical trials of 1,832 patients who were assigned either the drug, a placebo or another antiviral flu treatment within 48 hours of experiencing flu symptoms. In both trials, Xofluza patients’ symptoms were alleviated more quickly compared with the placebo. In the second trial, there was no difference in time to relieve symptoms between those who took Xofluza and another flu treatment. The most common adverse reactions to Xofluza included diarrhea and bronchitis.

More than 900,000 people were hospitalized and more than 80,000 people died from the flu in the U.S. in the 2017-18 season.