a new drug the company claims will kill the flu virus in one day. fast-track approval to begin immediately selling Xofluza in Japan, but the pill might not be available before May because a price hasn’t been set, the company told The Wall Street Journal.
Japanese regulators considered data from a first late-stage trial in making their decision. Xofluza, which was developed in 2015, is the first drug to be approved through the fast-track review system, .Shionogi and Switzerland’s Roche, which has the rights to sell the drug outside Japan, including the United States, are in final stages of a second late-stage trial. They plan to file for U.S. approval after the second trial.
In a late-stage trial on Japanese and American flu patients, the median time Xofluza took to rid the virus was 24 hours.
Roche’s Tamiflu, among the few drugs to treat people infected with the flu, took three times longer in the trial. Xofluza needs only a single dose compared with Tamiflu over five days.
Existing drugs are slow acting, allowing the virus to hijack cells and prevent new viral material from escaping and infecting other cells.