Genentech Gains FDA Approval for New Flu Drug
October 24 2018 - 2:05PM
Dow Jones News
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 stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
October 24, 2018 13:50 ET (17:50 GMT)
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