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The first new
influenza drug in 20 years was approved in October, and maker
Genentech says Xofluza began reaching pharmacies recently —
good timing for flu season.
With a single
pill, Xofluza can shorten the fevers, chills, sore throat, and
other symptoms that make a bout of the flu so miserable.
That’s not to
suggest Xofluza is magical. It has limitations, just like
Tamiflu, the well-known antiviral that has been around for 20
years. Experts still urge that you get the flu vaccine to
reduce your chance of infection.
But as U.S.
Food and Drug Administration Commissioner Scott Gottlieb said
in announcing its approval, Xofluza “provides an important,
additional treatment option.”
Here are things
to consider about that option — and the flu.
A mutating
target. Last flu season was the worst in decades, sickening 49
million people and killing 79,000. The dominant virus strain
mutated and undercut the effectiveness of the vaccine, which
is made each year to try to match circulating strains. On top
of that, far fewer people got flu shots. It isn’t yet clear
how bad this season will be, but so far, federal surveillance
shows little or no flu activity in most states, including
Pennsylvania and New Jersey.
The window of
opportunity. Xofluza (baloxavir marboxil) works by preventing
the virus from copying itself, while Tamiflu (oseltamivir
phosphate) and two similar drugs keep the virus from spreading
within the body. Either way, antivirals should be given within
48 hours of the first symptoms to be effective. Ebbing
Lautenbach, chief of infectious diseases at the University of
Pennsylvania, said the flu usually hits hard and suddenly —
unlike, say, a cold. “But it still requires a patient to
feel lousy and then fairly quickly contact their provider,”
he said. “If you’re outside the 48-hour window, there’s
not much to be gained” from an antiviral.
Suffering less.
Flu symptoms typically last from five to seven days. In the
two clinical trials that led to approval, Xofluza provided
relief more quickly than a placebo — by 26 hours. Xofluza
and Tamiflu were similar in shortening suffering. As for side
effects, Xofluza had no more than a placebo, while Tamiflu may
sometimes cause nausea and vomiting.
Simpler to use.
Xofluza is a single dose, unlike Tamiflu, which is taken twice
a day for five days. In theory, Xofluza could reduce the
problem of drug-resistant viruses emerging when patients
don’t finish their antiviral prescription. But studies of
Xofluza have shown that the virus may develop resistance after
just one dose.
Not for
everyone. Tamiflu is recommended for people at high risk of
flu complications such as pneumonia, including children and
older adults with chronic illnesses. Xofluza, in contrast, is
currently approved for people 12 and older. Genentech
continues to study the pill with an eye toward expanded
approval. It has already been shown to shorten the flu in
people at high risk of complications.
Cost. Xofluza
costs $150, but Genentech offers coupons to cut the
out-of-pocket cost for insured and uninsured patients. Tamiflu,
which is made by Roche, the parent company of Genentech, also
costs about $150. But generic oseltamivir is available for
less than $50, according to GoodRX.
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