On October 24, 2018, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours.  Manufactured by the Japanese pharmaceutical company Shionogi & Co., Ltd., this is the first new influenza antiviral approved in 20 years.  Studies of baloxavir have shown that when patients are treated within 48 hours of influenza symptom onset, the duration and severity of illness can be reduced.  The most common adverse reactions seen in clinical trials were diarrhea and bronchitis.

Baloxavir inhibits the influenza virus cap-dependent endonuclease, which differs from the mechanism of most commonly used influenza antiviral, oseltamivir (Tamiflu), which targets the viral neuraminidase protein.  Unlike oseltamivir which requires multiple days of therapy, baloxavir therapy requires only one weight-based oral dose (patients weighing at least 40 kg but less than 80 kg receive a single 40 mg dose; those weighing 80 kg or more receive a single 80 mg dose).

References

Click here for FDA Press Release.

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