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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, the Nikkei Asian Review reported.
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.
Shionogi, based in Osaka, is a 140-year-old company that has created blockbuster drugs used to treat HIV and high cholesterol.
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.
Xofluza blocks the flu virus from hijacking other human cellular, Shionogi Chief Executive Isao Teshirogi said.
Xofluza and Tamiflu took just as long to entirely contain flu symptoms. Besides offering faster relief, Shionogi said its drug reduces its contagious effects, including prevention of the rapid spread of infection to others.
Several other companies -- Johnson & Johnson, AstraZeneca PLC and a Merck & Co.-backed startup -- are testing new compounds to treat influenza A, the most common flu strain that infects humans.
The new Japanese drug can also treat influenza B strains, the company said.
Source: UPI
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