Published: Sun, October 28, 2018
Medical | By Vicki Mclaughlin

FDA approves first new drug to treat influenza in two decades

FDA approves first new drug to treat influenza in two decades

Xofluza is cleared to treat acute uncomplicated flu in patients 12 years and older who have had flu symptoms for no more than 48 hours.

An exceptionally harsh U.S. flu season previous year resulted in more than 900,000 people getting hospitalized and more than 80,000 deaths, according to estimates here from the U.S. Centers for Disease Control and Prevention. "This novel drug provides an important, additional treatment option", said FDA Commissioner Scott Gottlieb, M.D. According to the Centers for Disease Control and Prevention (CDC), last year's flu season was a doozy-an estimated 80,000 people died of the flu and its complications last winter, per the Associated Press.

And preliminary evidence suggests that Xofluza might be effective against strains of flu that have developed resistance to Tamiflu, though this has yet to be confirmed in clinical studies.

Xofluza is not a substitute for the annual flu shot.

"This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in almost 20 years", FDA Commissioner Scott Gottlieb, M.D., said in the release yesterday.

The most common adverse events reported were diarrhea (3.0 percent), bronchitis (2.6 percent), nausea (1.3 percent) and sinusitis (1.1 percent), and all of these adverse events occurred at a lower frequency than placebo.

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Each year, an estimated 3-11 percent of the US population gets the flu, and it can be very serious, resulting in hospitalization or even death.

Xofluza is said to work about as well as Tamiflu, Roche's older flu treatment. It's more convenient than Tamiflu, which is given in 10 pills over the course of five days. Roche has the rights to market Xofluza everywhere but Japan and Taiwan.

While there are now "several FDA-approved antiviral drugs to treat flu", they're not a subsitute for the seasonal flu vaccine, Dr. Gottlieb said Wednesday. The treatment will cost $150, although patients with commercial insurance may be able to access the drug for $30. That said, the new drug did not eliminate symptoms any faster than other available flu treatments. Those who are pregnant, plan to become pregnant, or are breastfeeding should also talk to their doctor before taking Xofluza, since its effects on an unborn baby or infants are unknown.

Flu treatments generally work best if taken within 48 hours of symptoms beginning. Although vaccines are an important first line of defense in preventing the flu, there is a need for new medical options for prophylaxis and treatment.

Also, reminder: These drugs are meant to help speed up your recovery once you have the flu.

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