FDA approves first flu drug in 20 years; Shionogi expects US$ 3 billion in sales

By PharmaCompass

2018-11-01

Impressions: 150 Article

On March 1, PharmaCompass had carried news that Japan had approved Shionogi & Co Ltd.’s Xofluza — a pathbreaking drug that cures flu with just one dose. The drug is a treatment for influenza A and influenza B.

Last week, the US Food and Drug Administration (FDA) also approved Xofluza (baloxavir marboxil). In a statement, the FDA Commissioner Scott Gottlieb, said: “This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years.”

The single dose feature gives Xofluza an edge over other neuraminidase inhibitors like Tamiflu and Relenza. For example, Tamiflu typically requires two doses each day for five days. Therefore, there are nine more doses of Tamiflu required, as compared to Xofluza.

Shionogi aims to double the global market for flu treatment with Xofluza. Bolstered by an early approval for the new drug, Shionogi raised its full-year operating profit outlook to 124.5 billion yen (US$ 1.11 billion), beating the average market estimates of 121.08 billion yen (US$ 1.07 billion).

“While the global market of flu drug is said to be about US$ 1 billion to US$ 1.5 billion, we want to expand it to around US$ 3 billion,” Shionogi CEO Isao Teshirogi said.

Though the FDA approval for Xofluza has been granted to Shionogi, Genentech (a member of the Roche Group) will be marketing the medication in the US.

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