New Flu Drug Fast-Tracked by FDA

From the WebMD Archives

June 27, 2018 -- A company developing a one-dose pill to treat flu says the drug has been fast-tracked by the U.S. Food and Drug Administration.

The FDA granted priority review to baloxavir marboxil and will decide whether to approve it by the end of this year, according to drug maker Genentech, NBC Newsreported.

If approved, the drug would be the first new flu drug to be introduced in the U.S. in years, and the first in 20 years with a different approach to fighting the flu. The drug, which was developed with the support of the U.S. National Institutes of Health, is already approved in Japan.

Flu drugs currently available in the U.S. include the pill Tamiflu; an inhalable product Relenza, and an injectable drug called peramivir. All three are designed to stop the flu virus from spreading inside the body.

Baloxavir uses a different approach. It interferes with a protein inside the flu virus, the Post reported.