Genentech Gains FDA Approval for New Flu Drug

   By Stephen Nakrosis 
 

Genentech said Wednesday the U.S. Food and Drug Administration approved Xofluza for the treatment of acute, uncomplicated influenza in people 12 years of age and older.

Xofluza has demonstrated efficacy against a wide range of influenza viruses, and it is the first and only single-dose oral medicine approved to treat the flu, the company said.

"This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years," said FDA Commissioner Scott Gottlieb, M.D. "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."

The new drug was approved based on results from the Phase 3 CAPSTONE-1 study of a single dose of Xofluza compared with placebo or oseltamivir--which is sold under the name Tamiflu--twice daily for five days, in otherwise healthy people with the flu, as well as results from a placebo-controlled Phase 2 study in otherwise healthy people with the flu.

Xofluza significantly reduced the duration of flu symptoms compared to placebo, and demonstrated similar efficacy compared to oseltamivir. In clinical trials, the drug was safe and well-tolerated with a side effect profile similar to placebo.

Genentech is a member of the Roche Group.

--Write to Stephen Nakrosis at [e-mail]

(END) Dow Jones Newswires

October 24, 2018 13:50 ET (17:50 GMT)

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