FDA approves Xofluza, a new anti-influenza drug

By RACHEL HUANG | November 15, 2018

Everyone knows about the infamous influenza. A contagious respiratory illness that spreads like wildfire, influenza infects approximately five to 20 percent of the U.S. population every year. 

In most cases, the flu tends to be resolved by the immune system itself. However, according to the Centers for Disease Control and Prevention (CDC), each year, there are about 31.4 million outpatient visits, 200,000 hospitalizations and more than $87 billion spent in response to the flu.

The flu is caused by a virus that infects the nose, throat and in extreme cases, the lungs. Due to its viral nature, the flu cannot be treated by antibiotics, and most treatments are directed toward addressing the symptoms. 

Although anyone can catch the flu, some are at a higher risk than others of developing complications from the infection. To name a few, children under the age of five, adults over the age of 65 and pregnant women are more likely to develop complications that progress to bacterial pneumonia, ear infections or sinus infections. 

Influenza is highly contagious because it is able to travel by tiny droplets through the air. The virus can also be transferred by touching infected objects and then touching one’s face, eyes and mouth. A person is contagious from the day before symptoms develop to seven days after symptoms develop.

The best defense against the flu is prevention, namely vaccines. The flu vaccine has been shown to prevent 6.6 million flu-related illnesses, 32 million flu-related medical visits and 79,000 hospitalizations.

With the prevalence of the flu still high, it’s important to have treatment options available once a person contracts the flu. 

The U.S. Food and Drug Administration (FDA) recently approved the use of Xofluza (baloxavir marboxil), an anti-flu drug administered to those 12 years or older.

Debra Birnkrant, the director of the Division of Antiviral Products at the FDA’s Center for Drug Evaluation and Research, explained why there is a need for new flu vaccines. 

“[The] antiviral drugs can lessen symptoms and shorten the time patients feel sick. Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs,” Birnkrant said in a press release.

Xofluza works by preventing the virus from replicating. Normally a virus infiltrates the host cell and tricks it into creating copies of the virus, which will go on to infect other host cells. Xofluza belongs to a class of endonuclease inhibitors which work by disrupting the virus’ ability to replicate, which in turn decreases the severity of the flu. 

Xofluza is taken as a single dose depending on the body weight of the individual. It has been shown to be most effective if taken within 48 hours after the appearance of the first symptom. Patients who took Xofluza within 24 hours felt better about 33 hours sooner than those who were left untreated. 

FDA Commissioner Scott Gottlieb described why Xofluza is important. 

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” Gottlieb said in a press release. “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.”

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