FDA approves new drug to treat influenza

As the influenza season gets under way in the United States, FDA has approved baloxavir marboxil (Xofluza—Shionogi & Co.) for the treatment of acute uncomplicated influenza in individuals aged 12 years and older who have been symptomatic for no more than 48 hours.

As the influenza season gets under way in the United States, FDA has approved baloxavir marboxil (Xofluza—Shionogi & Co.) for the treatment of acute uncomplicated influenza in individuals aged 12 years and older who have been symptomatic for no more than 48 hours. "This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical," said FDA Commissioner Scott Gottlieb, MD. He also stressed the importance of annual vaccination against influenza. In two randomized controlled clinical trials involving more than 1,800 patients, individuals who received baloxavir marboxil had a shorter time to alleviation of symptoms compared with those who took a placebo. The second trial also showed there was no difference in the time to alleviation of symptoms between patients who took baloxavir marboxil and those who received another antiviral influenza drug. Diarrhea and bronchitis were the most common adverse reactions in patients taking baloxavir marboxil.