First new flu drug in 20 years gets FDA approval

In a boon to everyone who dreads suffering through the flu, the FDA has just approved the first new flu drug in 20 years.

Xofluza (baloxavir marboxil) is a fast-acting treatment that is taken in a single dose, unlike Tamiflu. Brought to the U.S. market by Genentech, a division of Roche, the new drug comes just in time for flu season to officially arrive. On the heels of last year’s deadly flu season, in which about 80,000 Americans died of the flu or its consequences, health officials are warning people to take precautions, such as getting the flu shot. This new pill, which lessens the length and severity of the illness, may be another line of defense.

“With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical,” said FDA Commissioner Scott Gottlieb in the agency’s statement announcing the approval. “This novel drug provides an important, additional treatment option.”

Xofluza was approved for use in people 12 and older who have been experiencing flu symptoms for no more than 48 hours. The first in a new class of drug called endonuclease inhibitors, it works by interrupting viral replication, in which hordes of viruses take over the workings of cells to make legions of copies of themselves and spread the infection.

One thing to keep in mind is that you have to act fast when taking the new drug, which should be available in a few weeks. Xofluza must be taken quickly for maximum effect. Studies found that people who took the pill within 24 hours of the start of symptoms felt better 33 hours sooner than people whose flu was untreated, as the Scientific American reports. People who started the drug later only sped up their recovery by about 13 hours.

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