FDA approves first-of-its-kind flu drug

Oct. 29, 2018

For the first time in almost 20 years, the FDA has approved a new treatment for the flu. 

Developed by Japan’s Shionogi and Co, the drug, called Xofluza, is administered with a single dose, and can be used by patients over 12 who have had flu symptoms for no more than 48 hours. In clinical trials, the drug decreased the duration of symptoms from 102 hours (in patients given a placebo) to about 73 hours. 

Xofluza will be marketed globally Roche, who developed the current standard flu treatment, Tamiflu, which has to be taken twice a day for five days. 

Shionogi raised its full-year operating outlook following the approval, and said it hopes to expand the global flu market from $1 billion to $3 billion.  

The CDC estimates that about 9.2 million-35.6 million people in the U.S. contract the flu each year, resulting in an average of 12,000-56,000 deaths per year.

Genentech, a subsidiary of Roche, also announced earlier this year that the FDA had accepted its New Drug Application (NDA) and granted priority review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The FDA is expected to make a decision on that approval by Dec. 24, 2018.

Read the full Reuters report.