FDA Approves Xofluza for Treatment of Flu
The FDA approved Xofluza (baloxavir marboxil) for treatment of acute uncomplicated influenza in patients 12 and older.
The drug, manufactured by Shionogi, is the first new antiviral flu treatment with a novel mechanism of action the agency has approved in nearly two decades.
The agency based its approval on the results of two clinical trials of 1,832 patients after granting the application priority review.
The most common adverse reactions in trial subjects for the drug included bronchitis and diarrhea.