FDA Approves First New Flu Medication in 20 Years: What to Know

The pill works by interfering with the flu virus’ ability to replicate. The drug should be available in a few weeks.

Every year, the seasonal flu virus infects 5 to 20 percent of Americans and can lead to tens of thousands of deaths. Last year, 80,000 deaths were attributed to the virus.

Despite the toll the flu takes every year, there are rarely new ways to fight back against it.

Today, however, the U.S. Food and Drug Administration (FDA) announced that they’ve approved the drug baloxavir marboxil (Xofluza) to treat influenza.

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

A Japanese pharmaceutical company announced the development of the flu treatment earlier this year.

Clinical trials began this summer in the United States. The first results were announced in September.

An FDA approval had been expected in late December, but the agency announced the approval of Xofluza two months earlier than that.

As we head into the middle of flu season, here’s what you need to know about the new pill.

Who can get it?

The medication is approved for people over the age of 12.

Genentech, which is releasing the drug, said it’ll become widely available in the coming weeks.

The prescription drug should only be taken within the first 48 hours of flu symptoms.

What is it?

The antiviral drug helps stop the influenza virus from replicating.

It must be administered within the first 48 hours of symptoms in order to be effective.

What does it do?

Dr. Robert Glatter, an emergency room physician at Lennox Hill Hospital in New York, explains that the drug works by interrupting the virus’ ability to replicate.

It disrupts this cycle earlier than current antiviral medications, such as Tamiflu.

“This takes a step back and acts at many steps sooner [to] stop reproduction of the virus and replication of the virus,” Glatter told Healthline.

The FDA approved the drug after multiple clinical trials found it alleviated flu symptoms and helped shorten the duration of these symptoms compared to people who took a placebo.

While Xofluza works to stop viral replication earlier than Tamiflu, Glatter points out that the outcomes between people taking Tamiflu or Xofluza were similar.

“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 Dr. Debra Birnkrant, 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.”

Are there side effects?

The top side effects found in the studies were diarrhea and bronchitis, according to the FDA.

Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Tennessee, says that researchers found evidence the drug causes some flu strains to become resistant to antiviral medication, similar to how bacteria can become resistant to antibiotics.

“When it comes to treating those influenza A infections, it seems to work extremely well, but resistance seems to be developing fairly readily,” Schaffner said. “Those resistant viruses can be transmitted to others… This is not a problem with Tamiflu.”

Schaffner also says that to treat influenza type B, which can often become more dominant in spring months, more medication may be needed.

Flu shot still the best protection

Both Glatter and Schaffner stress that the flu vaccine is still the best way to protect yourself from the flu this winter.

“The vaccine helps to reduce complications of the flu as well as the intensity of the flu,” Glatter said.

Even if you end up contracting the flu after getting the vaccine, it “reduces the chance of complications, especially pneumonia,” Glatter said.

The bottom line

For the first time in 20 years, there’s a new flu medication available.

The drug called Xofluza helps stop the replication the flu virus inside your body.

Instead of multiple pills over days, Xofluza can be administered in just one pill.

Side effects include diarrhea and bronchitis.

Some experts are concerned it could lead to certain flu types developing antiviral resistance.

The treatment should be available in the coming weeks.

Source: FDA Approves First New Flu Medication in 20 Years: What to Know