The FDA just approved the first new flu treatment in nearly 20 years

  • The Food and Drug Administration has approved Genentech's Xofluza.
  • Last year, more than 80,000 people died from influenza and more than 900,000 were hospitalized, according to the Centers for Disease Control and Prevention.
  • While approving Xofluza, the FDA reminds people that it is not a replacement for the flu vaccine.
Simone Groper receives a flu shot at a Walgreens pharmacy on January 22, 2018 in San Francisco.
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Simone Groper receives a flu shot at a Walgreens pharmacy on January 22, 2018 in San Francisco.

The Food and Drug Administration has approved Xofluza, the first new antiviral flu treatment in nearly 20 years.

Genentech's Xofluza, baloxavir marboxil, is meant to treat acute uncomplicated influenza in patients 12 years and older who have had symptoms for no more than 48 hours. Genentech is a unit of Roche, which produces Tamiflu, a commonly used flu treatment.

The single-dose treatment will be available across the U.S. in the coming weeks, a Genentech spokesman told CNBC. It will cost $150 but may be available to some patients with commercial insurance for $30, he added.

Last year was a particularly nasty flu season: More than 80,000 people died and more than 900,000 were hospitalized, according to the Centers for Disease Control and Prevention.

"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.

— CNBC's Jodi Gralnick contributed to this report

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