Flu Drug Xofluza's Approval Ends 20 Year Drought

The U.S. Food and Drug Administration (FDA) approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza. 

Xofluza is an antiviral drug now approved for patients 12 years of age and older, who have been symptomatic for no more than 48 hours. 

Xofluza is already licensed in Japan and is being brought to the USA market by Genentech.

The safety and efficacy of Xofluza taken as a single oral dose were demonstrated in 2 randomized controlled clinical trials.   

In both trials, patients treated with Xofluza had a shorter time to alleviation of symptoms compared with patients who took the placebo.   

In the second trial, there was no difference in the time to alleviation of symptoms between subjects who received Xofluza and those who received the other flu treatment. 

Additionally, the results of a recent phase III CAPSTONE-2 study showed treatment with Xofluza significantly reduced the time to the improvement of influenza symptoms versus placebo. 

The median time of Xofluza improvement was 73.2 hours versus 102.3 hours in people at high risk of serious complications from the flu. 

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. This novel drug provides an important, additional treatment option,” said FDA Commissioner Scott Gottlieb, M.D. 

“While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination.” 

“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. 

“Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs.” 

“The seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations,” said Dr. Gottlieb. 

Flu is a contagious respiratory illness caused by influenza viruses, says the FDA. When patients with the flu are treated within 48 hours of becoming sick, antiviral drugs can reduce symptoms and duration of the illness. 

The most common adverse reactions in patients taking Xofluza included diarrhea and bronchitis.

The U.S. Centers for Disease Control and Prevention (CDC) recommends getting vaccinated by the end of October each year. 

Most pharmacies in the USA offer several FDA approved flu and vaccines. 

The CDC Vaccine Price List provides the private sector prices for general information. Flu vaccine discounts can be found here. 

Vaccines, like any medicine, can have side effects. You are encouraged to report negative side effects of vaccines to the FDA or CDC. 

Recent influenza vaccine news:

• Cell-Culture and Egg-Based Flu Vaccines Similarly Un-Effective Against Influenza A
• High-Dose Flu Shot 30% More Effective at Reducing Senior Hospitalizations