FDA regulation endangering flu victims in the USA--people dying while FDA stands in way

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As Americans suffer through the worst influenza outbreak in almost a decade, a Japanese drugmaker says it has developed a pill that can kill the virus within a day. But even if the experimental drug lives up to the claim, it likely won’t be available in the U.S. until next year at the earliest.

A late-stage trial on Japanese and American flu patients found that for the people who took the Shionogi 4507 -3.04% & Co. compound, the median time taken to wipe out the virus was 24 hours. That is much quicker than any other flu drug on the market, including Roche AG’s RHHBY -0.07% Tamiflu, which the trial showed took three times longer to achieve the same result. Quickly killing the virus could reduce its contagious effects, Shionogi said.

Also, Shionogi’s experimental drug requires only a single dose, while patients need to take two doses of Tamiflu a day, for five days.

Both Shionogi’s compound and Tamiflu take roughly the same amount of time to entirely contain flu symptoms, but Shionogi says its compound provides immediate relief faster.

Scientists at the Japanese company leveraged their work on a blockbuster anti-HIV drug to create the compound, which works differently from existing flu medicines. It blocks the flu virus from hijacking human cellular machinery, Chief Executive Isao Teshirogi said. Switzerland’s Roche has acquired the international license to distribute Shionogi’s experimental drug.

Flu Fighter

A Japanese company says it can prevent the flu virus from hijacking human cells.

“The data that we’ve seen looks very promising,” said Martin Howell Friede, who leads the World Health Organization’s advisory on vaccines, including for influenza. “This could be a breakthrough in the way that we treat influenza.”

Shionogi said Japan’s drug regulator is fast-tracking its approval and could approve it for use in Japan as early as March. The regulator declined to comment. Roche and Shionogi say they will apply for U.S. approval this summer and Shionogi doesn’t expect a decision until next year.

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Other players including Johnson & Johnson , AstraZeneca PLC and a startup backed by Merck & Co. are testing new compounds to treat influenza A, the most common flu strain.

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