A single oral dose of Xofluza (baloxavir marboxil) from Genentech (a unit of Roche Group, which produces Tamiflu) will be used for the treatment of uncomplicated flu in patients aged 12 and older who have had symptoms for no more than 48 hours. The pill was initially developed by Shionogi of Japan. It can reduce symptoms and duration of the illness. In trial, Xofluza reduced the amount of time a person was sick by a little more than a day.
Xofluza side effects were diarrhea, nausea, headaches and bronchitis and occurred at about the same rate as study participants given Tamiflu or placebo pills.”This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Dr. Scott Gottlieb said in a statement Wednesday. The new drug will be available across the U.S. in the coming weeks. It will cost $150 but may be available to some patients with commercial insurance for $30. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” FDA motivated. However, Xofluza is not a replacement for the flu vaccine, the agency warned. Health officials have said an estimated 80,000 Americans died of flu and its complications last winter.