First new flu drug in 20 years approved

In a boon to everyone who dreads suffering through the flu this year, the Food and Drug Administration has just approved the first new flu drug in 20 years.

Xofluza ( baloxavir marboxil) is a fast-acting treatment taken in a single dose. Brought to the U.S. market by Genentech, a division of Roche, the new drug comes just as flu season is set 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 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 a statement announcing the approval. “This novel drug provides an important, additional treatment option.”

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

But 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, according to Scientific American.

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,” Dr. Debra Birnkrant, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

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

Common side effects include diarrhea and bronchitis. Also, the pill will cost $150, as The New York Times notes, but Genentech will be offering coupons to cut the price to $30 for patients with health insurance and $90 for the uninsured.