"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," FDA Commissioner Dr. Scott Gottlieb said in a statement.
The FDA in June granted Xofluza priority review based on results of the Phase 3 CAPSTONE-1 study. Results from the trial, published in the New England Journal of Medicine, showed Xofluza reduced the amount of time a person was sick by a little more than a day.
"XOFLUZA is the first new flu medicine with a novel proposed mechanism of action approved in nearly 20 years, and we're excited to offer a convenient treatment option that reduces flu symptoms by more than a day with a single oral dose," Dr. Sandra Horning, chief medical officer and head of global product development at Genentech, said in a statement.
While the drug can treat the flu, the FDA in approving the drug reminds people that it is not a replacement for the flu vaccine. The CDC recommends getting vaccinated by the end of October.
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