Wednesday, 24 October 2018

F.D.A. Approves New Drug for Flu

New Drug for Flu


The first new flu drug in 20 years won approval Wednesday from the Food and Drug
Administration.
The new antiviral generically referred to as baloxavir marboxil but sold under the brand
name Xofluza is a single dose treatment. It is to be used only in those aged 12 or more, the
F.D.A. said and will be taken only within the first two days after symptoms like fever,
aches and sniffles appear.
The pill will cost $150, consistent with a spokeswoman for Genentech, which can sell Xofluza
in this country. Genentech will offer coupons that lower the worth to $30 for patients with
health insurance and to about $90 for the uninsured.
Flu season has already begun, and last years was one among the foremost lethal in decades;
about 80,000 Americans died of flu or its consequences, the Centers for Disease Control
and Prevention said earlier this month.
The new drug is not any miracle cure and it's not approved for young children, who are one
of the most vulnerable groups, so the C.D.C. still strongly recommends that every
American over the age of six months get a flu shot as soon as possible.
Several other anti-flu drugs exist — the best-known of which is oseltamivir, sold as
Tamiflu — but none cure the illness quickly.
Also, the influenza virus mutates very rapidly and has split into many strains that
circulate simultaneously each winter, and a number of other have evolved resistance to older drugs.
“Having safe and effective treatment alternatives is critical,” said Dr. Scott Gottlieb, the
F.D.A. commissioner, in a statement. “This novel drug provides an important additional
treatment option.”
Xofluza works during a new way, by blocking an enzyme the virus must copy itself. So, at
least in theory, circulating flu strains immune to earlier drugs shouldn't have any
resistance to it.
It has been shown to work against both A and B strains, which circulate each year, and it
is expected to figure against dangerous bird touches of flu known to sometimes infect humans,
such as the A strains of both H5N1 and A H7N9.
However, it's virtually inevitable that resistance to Xofluza will evolve as more people
use it. (To prevent that, doctors treat several diseases, including H.I.V. and tuberculosis,
with cocktails of three or four different drugs, but that's not the norm for flu treatment.)

Xofluza was invented by Shionogi, a Japanese company that also created the statin
Crestor.
It doesn't cure a bout of flu as rapidly as, for instance, antibiotics clear susceptible
bacterial infections. But it's going to alleviate some symptoms and shorten the time that
patients feel sick, said Dr. Debra Birnkrant, the F.D.A.’s director of antiviral products.
Xofluza was approved after two clinical trials in 1,832 patients. In both trials, those
treated with it recovered more quickly than those that got a placebo. In one trial, there
was no difference between Xofluza and Tamiflu.
Tamiflu, which is sold by Roche, Genentech’s parent company, is now available cheaply
as a generic drug. It requires two pills each day for five days.
Xofluza’s commonest side effects were diarrhea and bronchitis, the F.D.A. said.
Further research is underway to ascertain whether it's safe and effective in children and
whether it lowers rates of hospitalization and death.
In June, the F.D.A. granted Shionogi and Genentech “priority review” status, expediting
the approval process because it had been considered a crucial drug.

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