F.D.A. Approves new flu medicine



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The new drug, sold as Xofluza, is about as effective as Tamiflu in shortening the symptoms of the flu and is expected to work against drug-resistant strains.

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CreditCreditGenentech, via Associated Press
Donald G. McNeil Jr.

The first new influenza drug for 20 years was approved Wednesday by the Food and Drug Administration.

The new antiviral, known under the generic name of baloxavir marboxil but sold under the brand name Xofluza, is a single-dose treatment. It is intended for use only in 12 years and older, the F.D.A. said, and should be taken only in the first two days after the onset of symptoms such as fever, body aches and sniffles.

The pill will cost $ 150, according to a spokeswoman for Genentech, which will sell Xofluza in that country. Genentech will offer coupons that will reduce the price to $ 30 for patients with health insurance and about $ 90 for uninsured.

The flu season has already begun and last year, one of the deadliest in decades; Nearly 80,000 Americans have died of influenza or its consequences, the Center for Disease Control and Prevention said earlier. month.

The new drug is not a miracle cure and it is not approved for young children, who are one of the most vulnerable groups, so the C.D.C. always strongly recommends that all Americans over the age of six months get the flu shot as soon as possible.

There are several other anti-flu medications, the best known of which is oseltamivir, sold under the name Tamiflu, but none will cure the disease quickly.

In addition, the influenza virus mutates very rapidly and has split into several strains that circulate simultaneously each winter, and many have developed resistance to older drugs.

"Safe and effective alternative treatments are essential," said Dr. Scott Gottlieb, Director of the F.D.A. Commissioner, in a report. "This new drug provides an important additional treatment option."

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Xofluza works in a new way by blocking an enzyme that the virus needs to copy itself. Thus, at least in theory, circulating influenza strains that are resistant to previous drugs should not resist.

It has been shown to work against both strains A and B, which circulate annually, and against influenza of dangerous birds that can infect humans, such as strains A of H5N1 and A H7N9.

Donald G. McNeil Jr. is a science journalist covering the epidemics and diseases of the world's poor. He joined the Times in 1976 and reported on 60 countries.

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