What you need to know about Xofluza, the new flu medicine

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Consumer Reports has no financial relationship with the advertisers on this site.

A brand new drug designed to shorten the duration of the flu, baloxavir marboxil (Xofluza), has just been approved by the Food and Drug Administration.

"With thousands of people infected with the flu each year and many people seriously ill, safe and effective substitution treatments are essential," FDA Commissioner Scott Gottlieb, MD, said in a statement. "This new drug provides an important additional treatment option."

The drug is expected to be available for purchase in the coming weeks, in time for most of the influenza season, according to a spokesman for Genentech, the company that distributes Xofluza in the United States.

As the flu season accelerates, here are the answers to several key questions you may have about this new drug.

How it works?

Data from clinical trials suggest that Xofluza, approved for most healthy people over the age of 12, works as well as oseltamivir (Tamiflu and generic) – the most commonly used anti-influenza treatment – to reduce the duration of an illness. Overall, both appear to reduce the duration of flu symptoms from a little over three days to just over two days.

How is Xofluza different?

Like Tamiflu, it must be taken within 48 hours of the onset of symptoms to be effective. And for Xofluza, the sooner the better: In a clinical trial published in September in the New England Journal of Medicine (NEJM), people who took the drug within 24 hours of their illness had less symptoms than those who took it between 24 and 48 hours after the onset of flu symptoms.

The side effects seem to be similar to those of Tamiflu. In the NEJM study, approximately 20% of participants who received Xofluza experienced mild side effects, including diarrhea, bronchitis, nausea and sinus. The rates of these side effects were about the same for subjects in the study who received Tamiflu or placebo.

However, Xofluza only requires one dose. (The size of the dose depends on your weight.) Treatment with Tamiflu requires several doses over several days.

And preliminary evidence suggests that Xofluza may be effective against influenza strains that have developed resistance to Tamiflu, although this has not yet been confirmed by clinical studies.

Although Xofluza is approved only for healthy people 12 years of age and older, Tamiflu can be used in children as young as two weeks old. Tamiflu is also approved for pregnant women: Genentech currently advises women to tell their doctor if they are pregnant, planning to become pregnant or breastfeeding – before using Xofluza.

And unlike Tamiflu, Xofluza should only be used by people with a "simple" flu virus, which means that this is not the case for those who have become seriously ill with viral infection. Clinical trial data have not demonstrated the efficacy of the drug in people hospitalized for influenza, for example.

How much will it cost?

According to Genentech, Xofluza's retail price will be $ 150. But the company provides coupons to reduce the cost of the drug, available here. If your health insurer covers the drug, the coupon could reduce your costs to $ 30; otherwise, the coupon could reduce your price to $ 60.

Do I still need a flu shot?

Yes. According to the FDA, it is always best to prevent the flu and treat it with an antiviral. Although the flu shot is not perfect, it's the most effective step to stay healthy this winter.

And you should get the vaccine as soon as you can – it takes about two weeks for shot protection to be fully effective.

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