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FDA approves new, faster-acting flu drug

Xofluza is not a cure, but the singe-dose pill can reduce flu symptoms.

There’s a new drug to fight flu for the coming influenza season.

The Food and Drug Administration said Wednesday it had approved baloxavir, the first new influenza drug to hit the market in decades. It will be sold under the name Xofluza and should be available within a few weeks, the company that makes it said.

“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,” FDA Commissioner Dr. Scott Gottlieb said in a statement.

Baloxavir, sold under the name Xofluza, is the first new flu drug to hit the market in decades. It should be available within a few weeks.Genentech

The past flu season was an especially deadly one, with 80,000 deaths and more than 900,000 people put into the hospital by the virus.

Antiviral flu drugs don’t cure flu the way an antibiotic can cure strep throat, but can shorten the time people are sick and reduce the severity of their illness.

Xofluza appears to work more quickly than current flu drugs on the market, and with a single pill.

A 2016-2017 study in 1,436 people in the U.S. and Japan showed the pill cut the time people were sick to 2.5 days, from about 3.3 days. It cut how long people had a fever from an average of 42 hours to just one day. It also reduced what’s called viral shedding from four days to just one day.

Influenza viruses developed resistance long ago to the first two antiviral flu drugs, amantadine and rimantadine. Newer antiviral drugs on the market include Tamiflu, a pill; Relenza, which can be inhaled; and an injectable drug called peramivir.

All three are in a class called neuraminidase inhibitors. They help stop the virus from spreading inside the body and work best when given within a day or so of symptoms starting.

Baloxavir works in a different way. It interferes with a protein inside the flu virus called cap-dependent endonuclease protein.

It helps stop virus replication, also, but earlier on in the life cycle of the virus.

Doctors like having a variety of drugs on hand for any disease, but especially influenza, which mutates quickly and which can develop resistance to drugs. In 2009, for instance, the H1N1 swine flu strain developed resistance to Tamiflu.

“Xofluza is the first new flu medicine with a novel proposed mechanism of action approved in nearly 20 years, and we’re excited to offer a convenient treatment option that reduces flu symptoms by more than a day with a single oral dose,” said Dr. Sandra Horning, chief medical officer at Genentech, which sells the drug.

“If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms.”

The company said the wholesale cost for a course of Xofluza would be $150, which it said is equivalent to Tamiflu’s price. The company offered a coupon to lower the co-pay for people whose health insurance covers the drug.

Even though there are several drugs to fight flu, the best way to prevent flu is to get a vaccine, say the FDA, the Centers for Disease Control and Prevention and every major medical group.