Last year, the United States experienced one of the deadliest flu seasons in more than four decades. Data from the U.S. Centers for Disease Control and Prevention (CDC) show that, during this past winter, an estimated 80,000 Americans died from flu-related illnesses and complications — in a typical season, that number hovers around 30,000.
With flu season right around the corner, it’s more important than ever to arm yourself and your loved ones against the virus. And part of that line of defense will be baloxavir marboxil, the first influenza antiviral medication approved by the U.S. Food and Drug Administration (FDA) in nearly two decades, the agency announced Wednesday.
Baloxavir, which will be sold under the trade name Xofluza, is a single-dose medication intended to treat symptoms of acute uncomplicated influenza in people age 12 and older who have experienced flu symptoms for no more than 48 hours. In making its decision, the FDA evaluated results from two clinical trials, involving nearly 2,000 patients, that showed Xofluza to reduce the duration and severity of flu symptoms.
“With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “This novel drug provides an important, additional treatment option.”
Xofluza will join several other FDA-approved antiviral drugs on the market that treat influenza, such as Tamiflu, a five-day treatment. But Gottlieb still urged families to get their flu vaccinations if they haven’t done so already, as “yearly vaccination is the primary means of preventing and controlling flu outbreaks,” he said in the press statement.
Although effectiveness varies from year to year, the flu vaccine is responsible for keeping millions of people from becoming sick. During the 2016-2017 season, influenza vaccination prevented over 5 million flu illnesses and 85,000 flu-related hospitalizations, according to the CDC.
Still, there’s always a chance of catching the flu, even with vaccination. Certain flu strains, such as H3N2, can mutate quickly, which makes it more difficult to develop a vaccine targeted for that particular virus. What’s more, flu strains often change from one season to the next, weakening the efficacy of antiviral medication.
“Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs,” Debra Birnkrant, M.D., director of the FDA’s Division of Antiviral Products, said in a statement.
Xofluza will become available to patients across the United States within the coming weeks — and with a hefty price tag. The single-dose medication will cost $150, although some people may be able to get the drug at a discounted rate.